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Recent news from the US Food and Drug Administration.
Click title to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom. Press announcements from 2004 to 2009 are available through
the FDA
Archive.
FDA
Recalls: FDA posts press releases and other notices of recalls and
market withdrawals from the firms involved as a service to consumers,
the media, and other interested parties. FDA does not endorse either the
product or the company. This site does not contain a complete list of
recalls -
search for recalls at the official FDA site.
| December 30, 2020 - Coronavirus
(COVID-19) Update: December 30, 2020 |
| December 28, 2020 - Coronavirus
(COVID-19) Update: December 28, 2020 |
| December 28, 2020 - FDA
Approves First Generic of Drug Used to Treat Severe Hypoglycemia |
| December 23, 2020 - FDA
Takes Further Steps to Confront Opioid Crisis Through Risk Evaluation
and Mitigation Strategy Programs |
| December 23, 2020 - FDA
authorizes marketing of new device designed to remove dead pancreatic
tissue |
| December 22, 2020 - Coronavirus
(COVID-19) Update: December 22, 2020 |
| December 22, 2020 - FDA
Warns Companies Illegally Selling CBD Products |
| December 21, 2020 - Coronavirus
(COVID-19) Update: December 21, 2020 |
| December 18, 2020 - FDA
Takes Additional Action in Fight Against COVID-19 By Issuing Emergency
Use Authorization for Second COVID-19 Vaccine |
| December 18, 2020 - FDA
Approves First Adjuvant Therapy for Most Common Type of Lung Cancer |
| December 18, 2020 - FDA
Approves Prosthetic Implant for Above-the-Knee Amputations |
| December 18, 2020 - FDA
Approves First Oral Hormone Therapy for Treating Advanced Prostate
Cancer |
| December 17, 2020 - FDA
Statement on Vaccines and Related Biological Products Advisory Committee
Meeting |
| December 17, 2020 - Coronavirus
(COVID-19) Update: December 17, 2020 |
| December 17, 2020 - Trump
Administration Sets the Pace for Food Loss and Waste Reduction Efforts
to Continue |
| December 17, 2020 - FDA
Warns Consumers to Avoid Certain Male Enhancement and Weight Loss
Products Sold Through Amazon, eBay and Other Retailers Due to Hidden,
Potentially Dangerous Drug Ingredients |
| December 16, 2020 - Coronavirus
(COVID-19) Update: December 16, 2020 |
| December 16, 2020 - Actualización
sobre el coronavirus (COVID-19): La FDA emite una nueva autorización
para la prueba en el hogar BinaxNOW COVID-19 Ag Card |
| December 16, 2020 - FDA
Authorizes Marketing of New Implant to Repair a Torn ACL |
| December 16, 2020 - Coronavirus
(COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19
Ag Card Home Test |
| December 15, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter
Fully At-Home Diagnostic Test for COVID-19 |
| December 14, 2020 - Coronavirus
(COVID-19) Update: December 14, 2020 |
| December 14, 2020 - FDA
Approves First-of-its-Kind Intentional Genomic Alteration in Line
of Domestic Pigs for Both Human Food, Potential Therapeutic Uses |
| December 11, 2020 - FDA
Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use
Authorization for First COVID-19 Vaccine |
| December 11, 2020 - FDA
Statement on Vaccines and Related Biological Products Advisory Committee
Meeting |
| December 10, 2020 - Coronavirus
(COVID-19) Update: December 10, 2020 |
| December 10, 2020 - Coronavirus
(COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss
Authorization of COVID-19 Vaccine Candidate as Part of Agency’s
Review of Safety and Effectiveness Data |
| December 9, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19
Test System |
| December 8, 2020 - Coronavirus
(COVID-19) Update: December 8, 2020 |
| December 4, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First COVID-19 and Flu Combination
Test for use with home-collected samples |
| December 4, 2020 - Coronavirus
(COVID-19) Update: December 4, 2020 |
| December 3, 2020 - Coronavirus
(COVID-19) Update: December 3, 2020 |
| December 1, 2020 - Coronavirus
(COVID-19) Update: December 1, 2020 |
| December 1, 2020 - FDA
Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate
Cancer |
| November 30, 2020 - Coronavirus
(COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss
Second COVID-19 Vaccine Candidate |
| November 25, 2020 - Coronavirus
(COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of
Certain Respirators |
| November 24, 2020 - Coronavirus
(COVID-19) Update: November 24, 2020 |
| November 23, 2020 - FDA
Approves First Drug to Treat Rare Metabolic Disorder |
| November 23, 2020 - Coronavirus
(COVID-19) Update: November 23, 2020 |
| November 23, 2020 - FDA
Expands Approval of Influenza Treatment to Post-Exposure Prevention |
| November 21, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment
of COVID-19 |
| November 20, 2020 - Coronavirus
(COVID-19) Update: November 20, 2020 |
| November 20, 2020 - FDA
Approves First Treatment for Hutchinson-Gilford Progeria Syndrome
and Some Progeroid Laminopathies |
| November 20, 2020 - Coronavirus
(COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss
COVID-19 Vaccine Candidate |
| November 19, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes Drug Combination for Treatment of
COVID-19 |
| November 18, 2020 - FDA
Releases New Outbreak Investigation Table |
| November 17, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing
at Home |
| November 17, 2020 - Coronavirus
(COVID-19) Update: November 17, 2020 |
| November 17, 2020 - COVID-19
Update: FDA’s Ongoing Commitment to Transparency for COVID-19
EUAs |
| November 16, 2020 - Coronavirus
(COVID-19) Update: November 16, 2020 |
| November 16, 2020 - FDA
Approves First Intratumoral Injection to Treat Non-Metastatic Mast
Cell Tumors in Dogs |
| November 13, 2020 - Coronavirus
(COVID-19) Update: November 13, 2020 |
| November 12, 2020 - Coronavirus
(COVID-19) Update: November 12, 2020 |
| November 10, 2020 - Coronavirus
(COVID-19) Update: November 10, 2020 |
| November 10, 2020 - FDA
Encourages Manufacturers to Clearly Declare All Uses of Sesame in
Ingredient List on Food Labels |
| November 9, 2020 - Coronavirus
(COVID-19) Update: November 9, 2020 |
| November 9, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment
of COVID-19 |
| November 9, 2020 - FDA
Offers Guidance to Enhance Diversity in Clinical Trials, Encourage
Inclusivity in Medical Product Development |
| November 6, 2020 - FDA
Permits Marketing of New Device Designed to Reduce Sleep Disturbance
Related to Nightmares in Certain Adults |
| November 6, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First Test that Detects Neutralizing
Antibodies from Recent or Prior SARS-CoV-2 Infection |
| November 6, 2020 - FDA
Takes Efforts to Protect Patients from Potentially Harmful Compounded
Drugs Through Finalizing Insanitary Conditions Guidance |
| November 3, 2020 - Coronavirus
(COVID-19) Update: November 3, 2020 |
| October 30, 2020 - Coronavirus
(COVID-19) Update: October 30, 2020 |
| October 30, 2020 - FDA,
Homeland Security Agencies Take Additional Action to Prevent Import
of Illegal and Harmful Medical Products Through International Mail
Facilities |
| October 30, 2020 - FDA
Publishes List of Essential Medicines, Medical Countermeasures, Critical
Inputs Required by Executive Order |
| October 28, 2020 - Coronavirus
(COVID-19) Update: October 28, 2020 |
| October 27, 2020 - FDA
Approves Lotion for Nonprescription Use to Treat Head Lice |
| October 26, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 26, 2020 |
| October 23, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 23, 2020 |
| October 22, 2020 - FDA
Approves First Treatment for COVID-19 |
| October 20, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 20, 2020 |
| October 19, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 19, 2020 |
| October 15, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 15, 2020 |
| October 15, 2020 - FDA
Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved
Filtering Face-Piece Respirators Manufactured in China |
| October 15, 2020 - FDA
Warns that Using a Type of Pain and Fever Medication in Second Half
of Pregnancy Could Lead to Complications |
| October 14, 2020 - FDA
Approves First Treatment for Ebola Virus |
| October 13, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 13, 2020 |
| October 13, 2020 - FDA
Warns Dietary Supplement Companies Illegally Selling Products Containing
Cesium Chloride |
|
October 9, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 9, 2020
|
| October 8, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 8, 2020 |
| October 8, 2020 - FDA
awards six grants to fund new clinical trials to advance the development
of medical products for the treatment of rare diseases |
| October 8, 2020 - FDA
Reaffirms Commitment to Safety, Security of its Public Health Laboratories |
| October 7, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 7, 2020 |
| October 7, 2020 - FDA
Issues Warning Letter to Battelle Memorial Institute, a Manufacturer
of an Authorized Decontamination System Used on Respirators |
| October 6, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 6, 2020 |
| October 5, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 5, 2020 |
| October 5, 2020 - FDA,
Mexican Counterparts Enhance Food Safety Partnership |
| October 2, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 2, 2020 |
| October 2, 2020 - FDA
Approves Drug Combination for Treating Mesothelioma |
| October 1, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup October 1, 2020 |
| October 1, 2020 - USDA
and FDA Sign Memorandum of Understanding to Enhance Collaboration,
Efficiency on U.S. Dairy Exports |
| September 30, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 30, 2020 |
| September 28, 2020 - FDA
Issues Final Guidance for Certain Labeling Recommendations for Breast
Implants |
| September 25, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 25, 2020 |
| September 25, 2020 - FDA
Approves First Drug to Treat Group of Rare Blood Disorders in Nearly
14 Years |
| September 24, 2020 - FDA
Takes Actions to Help Lower U.S. Prescription Drug Prices |
| September 24, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 24, 2020 |
| September 24, 2020 - FDA
Issues Recommendations for Certain High-Risk Groups Regarding Mercury-Containing
Dental Amalgam |
| September 23, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test
for COVID-19 |
| September 23, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 23, 2020 |
| September 23, 2020 - FDA
Requiring Labeling Changes for Benzodiazepines |
| September 23, 2020 - FDA
Achieves Key Milestone, Finalizes Framework That Will Resume Shellfish
Trade with Europe for the First Time in 10 Years |
| September 22, 2020 - FDA
Launches the Digital Health Center of Excellence |
| September 22, 2020 - FDA
Clarifies Types of Evidence Relevant to Determining the “Intended
Use” of FDA-Regulated Products |
| September 21, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 21, 2020 |
| September 21, 2020 - FDA
Announces Key FSMA Rule to Advance Traceability of Foods, A Major
Milestone in the New Era of Smarter Food Safety |
| September 18, 2020 -
Coronavirus (COVID-19) Update: Daily Roundup September 18, 2020 |
| September 17, 2020 -
Coronavirus (COVID-19) Update: Daily Roundup September 17, 2020 |
| September 16, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 16, 2020 |
| September 15, 2020 - Coronavirus
(COVID-19) Update: FDA Publishes Comparative Performance Data for
COVID-19 Molecular Diagnostic Tests |
| September 15, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 15, 2020 |
| September 15, 2020 - FDA
issues first injunction under Produce Safety Rule to Illinois-based
food manufacturer for repeated food safety violations |
| September 14, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 14, 2020 |
| September 11, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 11, 2020 |
| September 10, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 10, 2020 |
| September 10, 2020 - FDA
Warns Website Operators Illegally Selling Opioids to Consumers |
| September 9, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 9, 2020 |
| September 9, 2020 - National
Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use,
Concerning Uptick in Use of Disposable Products |
| September 8, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 8, 2020 |
| September 4, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 4, 2020 |
| September 3, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 3, 2020 |
| September 2, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 2, 2020 |
| September 1, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup September 1, 2020 |
| September 1, 2020 - FDA
Provides Guidance to Industry for Detecting and Preventing Nitrosamines
in Drugs |
| August 31, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 31, 2020 |
| August 31, 2020 - FDA
Approves First-of-its-Kind Automated Insulin Delivery and Monitoring
System for Use in Young Pediatric Patients |
| August 28, 2020 - Coronavirus
(COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss
COVID-19 Vaccines |
| August 28, 2020 - COVID-19
Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir)
to Include All Hospitalized Patients for Treatment of COVID-19 |
| August 28, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 28, 2020 |
| August 27, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 27, 2020 |
| August 27, 2020 - COVID-19
Update: FDA Warns Consumers About Hand Sanitizer Packaged in Food
and Drink Containers |
| August 26, 2020 - COVID-19
Update: FDA Authorizes First Diagnostic Test Where Results Can Be
Read Directly From Testing Card |
| August 26, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 26, 2020 |
| August 25, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 25, 2020 |
| August 24, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 24, 2020 |
| August 23, 2020 - FDA
Issues Emergency Use Authorization for Convalescent Plasma as Potential
Promising COVID–19 Treatment, Another Achievement in Administration’s
Fight Against Pandemic |
| August 21, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 21, 2020 |
| August 20, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 20, 2020 |
| August 20, 2020 - FDA
Updates Analysis of Medical Device Reports of Breast Implant Illness
and Breast Implant-Associated Lymphoma |
| August 19, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 19, 2020 |
| August 18, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 18, 2020 |
| August 17, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 17, 2020 |
| August 17, 2020 - FDA
Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal
Cord |
| August 15, 2020 - Coronavirus
(COVID-19) Update: FDA Issues Emergency Use Authorization to Yale
School of Public Health for SalivaDirect, Which Uses a New Method
of Saliva Sample Processing |
| August 14, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 14, 2020 |
| August 14, 2020 - FDA
and CDC Use Technological Advancements to Investigate Multistate Outbreak
of Cyclospora Illnesses Linked to Bagged Salads |
| August 13, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 13, 2020 |
| August 12, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 12, 2020 |
| August 12, 2020 - FDA
Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation |
| August 12, 2020 - FDA
Finalizes Rule Related to Gluten-Free Labeling for Foods Containing
Fermented, Hydrolyzed Ingredients |
| August 11, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 11, 2020 |
| August 10, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 10, 2020 |
| August 7, 2020 -
FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled
Clinical Settings |
|
August 7, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 7, 2020
|
| August 7, 2020 - FDA
Approves First Liquid Biopsy Next-Generation Sequencing Companion
Diagnostic Test |
| August 7, 2020 - FDA
Approves Oral Treatment for Spinal Muscular Atrophy |
| August 6, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 6, 2020 |
| August 5, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 5, 2020 |
| August 4, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 4, 2020 |
| August 3, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup August 3, 2020 |
| July 31, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s
Antibodies from Past SARS-CoV-2 Infection |
| July 31, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 31, 2020 |
| July 31, 2020 - FDA
Approves New Indication for Drug Containing an Active Ingredient Derived
from Cannabis to Treat Seizures in Rare Genetic Disease |
| July 31, 2020 - FDA
Announces Voluntary Agreement with Manufacturers to Phase Out Certain
Short-Chain PFAS Used in Food Packaging |
| July 30, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 30, 2020 |
| July 30, 2020 -
FDA Announces New Protocol for the Development and Registration of
Treatments for Preharvest Agricultural Water |
| July 29, 2020 - FDA
Warns Companies Illegally Selling Hangover Remedies |
| July 29, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 29, 2020 |
| July 29, 2020 - Coronavirus
(COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter
Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices
or Schools |
| July 28, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 28, 2020 |
| July 27, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 27, 2020 |
| July 27, 2020 - Coronavirus
(COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based
Hand Sanitizers Containing Methanol, Takes Additional Action to Address
Concerning Products |
| July 24, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First Diagnostic Test for Screening
of People Without Known or Suspected COVID-19 Infection |
| July 24, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 24, 2020 |
| July 24, 2020 - FDA
Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed
or Refractory MCL |
| July 23, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 23, 2020 |
| July 23, 2020 - FDA
Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder
Medicines Regarding Naloxone |
| July 23, 2020 - FDA
Proposes New Rule on Reporting Requirements |
| July 22, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 22, 2020 |
| July 21, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 21, 2020 |
| July 20, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 20, 2020 |
| July 20, 2020 - FDA
Extends Enforcement Discretion Policy for Certain Regenerative Medicine
Products |
| July 20, 2020 - FDA
Notifies Companies, Including Puff Bar, to Remove Flavored Disposable
E-Cigarettes and Youth-Appealing E-Liquids from Market for Not Having
Required Authorization |
| July 18, 2020 - Coronavirus
(COVID-19) Update: FDA Issues First Emergency Authorization for Sample
Pooling in Diagnostic Testing |
| July 17, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 17, 2020 |
| July 16, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 16, 2020 |
| July 15, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 15, 2020 |
| July 14, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 14, 2020 |
| July 13, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 13, 2020 |
| July 13, 2020 - FDA
Launches New Era of Smarter Food Safety Initiative, Releases Blueprint
and Pilot Study |
| July 10, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 10, 2020 |
| July 10, 2020 - Coronavirus
(COVID-19) Update: FDA prepares for resumption of domestic inspections
with new risk assessment system |
| July 9, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 9, 2020 |
| July 8, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 8, 2020 |
| July 7, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 7, 2020 |
| July 7, 2020 - FDA
Approves New Therapy for Myelodysplastic Syndromes (MDS) That Can
Be Taken at Home |
| July 7, 2020 - FDA
Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced
Exposure’ Information |
| July 6, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 6, 2020 |
| July 6, 2020 - Coronavirus
(COVID-19) Update: FDA Issued Emergency Use Authorization for Point
of Care Antigen Test |
| July 2, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 2, 2020 |
| July 2, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes Additional COVID-19 Combination
Diagnostic Test Ahead of Flu Season |
| July 2, 2020 - FDA
Approves New HIV Treatment for Patients With Limited Treatment Options |
| July 2, 2020 - Coronavirus
(COVID-19) Update: FDA Takes Action to Warn, Protect Consumers from
Dangerous Alcohol-Based Hand Sanitizers Containing Methanol |
| July 1, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup July 1, 2020 |
| June 30, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 30, 2020 |
| June 30, 2020 - Coronavirus
(COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development
of Safe, Effective COVID-19 Vaccines |
| June 29, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 29, 2020 |
| June 29, 2020 - FDA
Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic
Colorectal Cancer |
| June 29, 2020 - FDA
Approves Breast Cancer Treatment That Can Be Administered At Home
By Health Care Professional |
| June 26, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 26, 2020 |
| June 25, 2020 - FDA
Approves New Therapy for Dravet Syndrome |
| June 25, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 25, 2020 |
| June 24, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 24, 2020 |
| June 24, 2020 - Coronavirus
(COVID-19) Update: Joint Statement from USDA and FDA on Food Export
Restrictions Pertaining to COVID-19 |
| June 23, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 23, 2020 |
| June 23, 2020 - FDA
Announces First of Its Kind Pilot Program to Communicate Patient Reported
Outcomes from Cancer Clinical Trials |
| June 22, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 22, 2020 |
| June 19, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 19, 2020 |
| June 18, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 18, 2020 |
| June 18, 2020 - FDA
Approves First Therapy for Rare Disease that Causes Low Phosphate
Blood Levels, Bone Softening |
| June 18, 2020 - Coronavirus
(COVID-19) Update: FDA Takes Additional Action to Harness Real-World
Data to Inform COVID-19 Response Efforts |
| June 17, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 17, 2020 |
| June 17, 2020 - Coronavirus
(COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately
Marketing Antibody Tests, Potentially Placing Public Health at Risk |
| June 16, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 16, 2020 |
| June 16, 2020 - Coronavirus
(COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic
Testing and Sample Pooling |
| June 16, 2020 - Coronavirus
(COVID-19) Update: FDA Revokes Emergency Use Authorization for Chembio
Antibody Test |
| June 16, 2020 - FDA
Approves First Treatment for Adult Onset Still’s Disease, a Severe
and Rare Disease |
| June 16, 2020 - FDA
Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as
Homeopathic |
| June 15, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 15, 2020 |
| June 15, 2020 - Coronavirus
(COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction
That May Reduce Effectiveness of a COVID-19 Treatment Authorized for
Emergency Use |
| June 15, 2020 - FDA
Permits Marketing of First Game-Based Digital Therapeutic to Improve
Attention Function in Children with ADHD |
| June 15, 2020 - Coronavirus
(COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine
and Hydroxychloroquine |
| June 12, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 12, 2020 |
| June 12, 2020 - FDA
Approves Drug to Treat Infants and Children with HIV |
| June 11, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 11, 2020 |
| June 11, 2020 - FDA
Approves New Therapy for Rare Disease Affecting Optic Nerve, Spinal
Cord |
| June 10, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 10, 2020 |
| June 10, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First Next Generation Sequence Test
for Diagnosing COVID-19 |
| June 9, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 9, 2020 |
| June 8, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 8, 2020 |
| June 8, 2020 - Federal
Government Announces New Pilot Program to Help Stop Illegal Availability
of Unapproved Opioids Online |
| June 7, 2020 - Coronavirus
(COVID-19) Update: FDA Reissues Emergency Use Authorizations Revising
Which Types of Respirators Can Be Decontaminated for Reuse |
| June 5, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 5, 2020 |
| June 4, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 4, 2020 |
| June 4, 2020 - Coronavirus
(COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data
From Kits as Part of Validation Study |
| June 4, 2020 - FDA
Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia
and Ventilator-Associated Bacterial Pneumonia |
| June 3, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 3, 2020 |
| June 2, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 2, 2020 |
| June 1, 2020 - Coronavirus
(COVID-19) Update: FDA Takes Action to Protect Public Health; Increase
Supply of Alcohol-Based Hand Sanitizer |
| June 1, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup June 1, 2020 |
| June 1, 2020 - Federal
judge enters order of permanent injunction against New York company
for distributing unapproved drugs |
| May 29, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 29, 2020 |
| May 29, 2020 - Coronavirus
(COVID-19) Update: FDA Takes Steps to Streamline Development of Tests
With At-Home Sample Collection |
| May 29, 2020 - FDA
Approves New Option to Treat Heavy Menstrual Bleeding Associated with
Fibroids in Women |
| May 28, 2020 - FDA
Alerts Patients and Health Care Professionals to Nitrosamine Impurity
Findings in Certain Metformin Extended-Release Products |
| May 28, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 28, 2020 |
| May 28, 2020 - FDA
Approves First Drug to Image Tau Pathology in Patients Being Evaluated
for Alzheimer’s Disease |
| May 27, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 27, 2020 |
| May 27, 2020 - Coronavirus
(COVID-19) Update: FDA Provides New Tool to Aid Development and Evaluation
of Diagnostic Tests That Detect SARS-CoV-2 Infection |
| May 26, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 26, 2020 |
| May 22, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 22, 2020 |
| May 21, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 21, 2020 |
| May 21, 2020 - Coronavirus
(COVID-19) Update: FDA Provides Promised Transparency for Antibody
Tests |
| May 21, 2020 - FDA
Releases Report on Investigation into Fall 2019 Outbreaks of Illnesses
Tied to Romaine Lettuce |
| May 20, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 20, 2020 |
| May 19, 2020 - USDA,
FDA Strengthen U.S. Food Supply Chain Protections |
| May 19, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 19, 2020 |
| May 19, 2020 - Coronavirus
(COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of
Real-World Data to Inform Pandemic Response |
| May 18, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 18, 2020 |
| May 26, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 26, 2020 |
| May 22, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 22, 2020 |
| May 21, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 21, 2020 |
| May 21, 2020 - Coronavirus
(COVID-19) Update: FDA Provides Promised Transparency for Antibody
Tests |
| May 21, 2020 - FDA
Releases Report on Investigation into Fall 2019 Outbreaks of Illnesses
Tied to Romaine Lettuce |
| May 20, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 20, 2020 |
| May 19, 2020 - USDA,
FDA Strengthen U.S. Food Supply Chain Protections |
| May 19, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 19, 2020 |
| May 19, 2020 - Coronavirus
(COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of
Real-World Data to Inform Pandemic Response |
| May 18, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 18, 2020 |
| May 16, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First Standalone At-Home Sample
Collection Kit That Can Be Used With Certain Authorized Tests |
| May 15, 2020 - FDA
Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal
Stromal Tumors |
| May 15, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 15, 2020 |
| May 14, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 14, 2020 |
| May 14, 2020 - Coronavirus
(COVID-19) Update: FDA Informs Public About Possible Accuracy Concerns
with Abbott ID NOW Point-of-Care Test |
| May 14, 2020 - Coronavirus
(COVID-19) Update: Federal judge enters temporary injunction against
Xephyr LLC doing business as N-Ergetics, preventing sale of Colloidal
Silver Products for COVID-19 |
| May 14, 2020 - FDA
issues warning letters to two breast implant manufacturers as part
of ongoing efforts to protect patients |
| May 13, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 13, 2020 |
| May 12, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 12, 2020 |
| May 11, 2020 - Coronavirus
(COVID-19) Update: FDA Takes New Actions to Accelerate Development
of Novel Prevention, Treatment Options for COVID-19 |
| May 11, 2020 - Coronavirus
(COVID-19) Update: FDA updates on surveillance inspections during
COVID-19 |
| May 11, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 11, 2020 |
| May 9, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First Antigen Test to Help in the
Rapid Detection of the Virus that Causes COVID-19 in Patients |
| May 8, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First Diagnostic Test Using At-Home
Collection of Saliva Specimens |
| May 8, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 8, 2020 |
| May 8, 2020 - FDA
Approves First Therapy for Patients with Lung and Thyroid Cancers
with a Certain Genetic Mutation or Fusion |
| May 7, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 7, 2020 |
| May 7, 2020 - Coronavirus
(COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical
Products |
| May 6, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 6, 2020 |
| May 6, 2020 - FDA
Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer |
| May 5, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 5, 2020 |
| May 5, 2020 - FDA
approves new treatment for a type of heart failure |
| May 4, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 4, 2020 |
| May 1, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup May 1, 2020 |
| May 1, 2020 - Coronavirus
(COVID-19) Update: FDA Issues Emergency Use Authorization for Potential
COVID-19 Treatment |
| April 30, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 30, 2020 |
| April 30, 2020 - Coronavirus
(COVID-19) Update: FDA Includes Ventilator Developed by NASA in Ventilator
Emergency Use Authorization |
| April 29, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 29, 2020 |
| April 29, 2020 - FDA
Grants Marketing of New Device for Continuous Dialysis Therapy for
use in Pediatric Patients with Certain Kidney Conditions |
| April 28, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 28, 2020 |
| April 27, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 27, 2020 |
| April 27, 2020 - FDA
Warns Manufacturers and Retailers to Remove Certain E-cigarette Products
Targeted to Youth from the Market |
| April 27, 2020 - Coronavirus
(COVID-19) Update: FDA Continues to Ensure Availability of Alcohol-Based
Hand Sanitizer During the COVID-19 Pandemic, Addresses Safety Concerns |
|
April 24, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 24, 2020
|
| April 24, 2020 - FDA
Provides Updates on Adverse Event Reports and Postmarket Activities
Associated with Essure |
| April 24, 2020 - Coronavirus
(COVID-19) Update: FDA Reiterates Importance of Close Patient Supervision
for ‘Off-Label’ Use of Antimalarial Drugs to Mitigate Known
Risks, Including Heart Rhythm Problems |
| April 23, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 23, 2020 |
| April 23, 2020 - FDA
Warns Companies Illegally Selling CBD Products to Treat Medical Conditions,
Opioid Addiction |
| April 23, 2020 - Coronavirus
(COVID-19) Update: Court Grants FDA’s Request for Extension of
Premarket Review Submission Deadline for Certain Tobacco Products
Because of Impacts from COVID-19 |
| April 22, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 22, 2020 |
| April 22, 2020 - FDA
Approves New Therapy for Triple Negative Breast Cancer That Has Spread,
Not Responded to Other Treatments |
| April 21, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 21, 2020 |
|
April 21, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes First Test for Patient At-Home
Sample Collection
|
| April 20, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 20, 2020 |
| April 18, 2020 - Coronavirus
(COVID-19) Update: Serological Test Validation and Education Efforts |
| April 17, 2020 - Coronavirus
(COVID-19) Update: Federal judge enters temporary injunction against
Genesis II Church of Health and Healing, preventing sale of Chlorine
Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19
|
| April 17, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 17, 2020 |
| April 17, 2020 - FDA
Approves First Targeted Treatment for Patients with Cholangiocarcinoma,
a Cancer of Bile Ducts |
| April 17, 2020 - FDA
Approves First New Drug Under International Collaboration, A Treatment
Option for Patients with HER2-Positive Metastatic Breast Cancer |
| April 16, 2020 - Coronavirus
(COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen,
and U.S. Cotton Collaborate to Address Testing Supply Needs |
| April 16, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 16, 2020 |
| April 16, 2020 - Coronavirus
(COVID-19) Update: FDA Continues User-Fee Related Reviews Through
COVID-19 |
| April 16, 2020 - Coronavirus
(COVID-19) Update: FDA Encourages Recovered Patients to Donate Plasma
for Development of Blood-Related Therapies |
| April 15, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 15, 2020 |
| April 15, 2020 - FDA
Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial
Cancer |
| April 14, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 14, 2020 |
| April 13, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 13, 2020 |
| April 12, 2020 - Coronavirus
(COVID-19) Update: FDA Issues Emergency Use Authorization to Decontaminate
Millions of N95 Respirators |
| April 10, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 10, 2020 |
| April 10, 2020 - FDA
Approves First Therapy for Children with Debilitating and Disfiguring
Rare Disease |
| April 10, 2020 - Coronavirus
(COVID-19) Update: FDA Issues Second Emergency Use Authorization to
Decontaminate N95 Respirators |
| April 10, 2020 - Coronavirus
(COVID-19) Update: FDA Authorizes Blood Purification Device to Treat
COVID-19 |
| April 9, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 9, 2020 |
| April 8, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 8, 2020 |
| April 8, 2020 - Coronavirus
(COVID-19) Update: FDA Warns Seller Marketing Dangerous Chlorine Dioxide
Products that Claim to Treat or Prevent COVID-19 |
| April 8, 2020 - FDA
Approves First Generic of a Commonly Used Albuterol Inhaler to Treat
and Prevent Bronchospasm |
| April 7, 2020 - Coronavirus
(COVID-19) Update: Serological Tests |
| April 7, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 7, 2020 |
| April 6, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 6, 2020 |
| April 3, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 3, 2020 |
| April 3, 2020 - Coronavirus
(COVID-19) Update: FDA Coordinates National Effort to Develop Blood-Related
Therapies for COVID-19 |
| April 2, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 2, 2020 |
| April 2, 2020 - Coronavirus
(COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent
Need for Blood During the Pandemic |
| April 1, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup April 1, 2020 |
| April 1, 2020 - FDA
Approves Additional Treatment for Adults and Adolescents with Hemophilia
A or B and Inhibitors |
| April 1, 2020 - FDA
Requests Removal of All Ranitidine Products (Zantac) from the Market |
| March 31, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup March 31, 2020 |
| March 31, 2020 - Coronavirus
(COVID-19) Update: FDA Continues to Accelerate Development of Novel
Therapies for COVID-19 |
| March 30, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup March 30, 2020 |
| March 30, 2020 - Coronavirus
(COVID-19) Update: FDA expedites review of diagnostic tests to combat
COVID-19 |
| March 30, 2020 - FDA
on Signing of the COVID-19 Emergency Relief Bill, Including Landmark
Over-the-Counter Drug Reform and User Fee Legislation |
| March 28, 2020 - Coronavirus
(COVID-19) Update: FDA takes further steps to help mitigate supply
interruptions of food and medical products |
| March 27, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup March 27, 2020 |
| March 27, 2020 - Coronavirus
(COVID-19) Update: FDA takes action to help increase U.S. supply of
ventilators and respirators for protection of health care workers,
patients |
| March 26, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup March 26, 2020 |
| March 26, 2020 - FDA
Continues to Support Transparency and Collaboration in Drug Approval
Process as the Clinical Data Summary Pilot Concludes |
| March 25, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup, March 25, 2020 |
| March 24, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup, March 24, 2020 |
| March 24, 2020 - Coronavirus
(COVID-19) Update: FDA takes action to increase U.S. supplies through
instructions for PPE and device manufacturers |
| March 24, 2020 - Coronavirus
(COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During
Pandemic |
| March 23, 2020 - Coronavirus
(COVID-19) Update: Daily Roundup |
| March 23, 2020 - Insulin
Gains New Pathway to Increased Competition |
| March 22, 2020 - Coronavirus
(COVID-19) Update: FDA provides update on patient access to certain
REMS drugs during COVID-19 public health emergency |
| March 22, 2020 - Coronavirus
(COVID-19) Update: FDA Continues to Facilitate Access to Crucial Medical
Products, Including Ventilators |
| March 21, 2020 - Coronavirus
(COVID-19) Update: FDA Issues first Emergency Use Authorization for
Point of Care Diagnostic |
| March 20, 2020 - Coronavirus
(COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent
COVID-19 Test Kits |
| March 20, 2020 - Coronavirus
(COVID-19) Update: FDA allows expanded use of devices to monitor patients’
vital signs remotely |
| March 20, 2020 - Coronavirus
(COVID-19) Update: FDA provides guidance on production of alcohol-based
hand sanitizer to help boost supply, protect public health |
| March 19, 2020 - Coronavirus
(COVID-19) Update: FDA Continues to Facilitate Development of Treatments |
| March 19, 2020 - Coronavirus
(COVID-19) Update: Blood Donations |
| March 19, 2020 - FDA
Approves New Treatment for Pediatric Patients with Any Strain of Hepatitis
C |
| March 18, 2020 - Coronavirus
(COVID-19) Update: FDA Focuses on Safety of Regulated Products While
Scaling Back Domestic Inspections |
| March 18, 2020 - Coronavirus
(COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials |
| March 17, 2020 - Coronavirus
(COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit
Requirements |
| March 17, 2020 - FDA
requires new health warnings for cigarette packages and advertisements |
| March 16, 2020 - Coronavirus
(COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization
to Hologic and LabCorp |
| March 16, 2020 - Coronavirus
(COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak,
Continues to Help Expedite Availability of Diagnostics |
| March 13, 2020 - Coronavirus
(COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo
Fisher |
| March 13, 2020 - Coronavirus
(COVID-19) Update: FDA gives flexibility to New York State Department
of Health, FDA issues Emergency Use Authorization diagnostic |
| March 11, 2020 - FDA
Launches New Campaign to Help Consumers Use the New Nutrition Facts
Label |
| March 10, 2020 - Coronavirus
Disease 2019 (COVID-19) Update: Foreign Inspections |
| March 10, 2020 - FDA
Warns Retailers, Manufacturers to Remove Unauthorized E-Cigarette
Products from Market |
| March 9, 2020 - FDA
Approves First Treatment for Group of Progressive Interstitial Lung
Diseases |
| March 9, 2020 - FDA
Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes
Medications |
| March 9, 2020 - Coronavirus
Update: FDA and FTC Warn Seven Companies Selling Fraudulent Products
that Claim to Treat or Prevent COVID-19 |
| March 6, 2020 - FDA
Approves New Treatment for Adults with Cushing’s Disease |
| March 5, 2020 - FDA
Advances Work Related to Cannabidiol Products with Focus on Protecting
Public Health, Providing Market Clarity |
| March 4, 2020 - New
‘Feed Your Mind’ Initiative Launches to Increase Consumer
Understanding of Genetically Engineered Foods |
| March 4, 2020 - FDA
Requires Stronger Warning About Risk of Neuropsychiatric Events Associated
with Asthma and Allergy Medication Singulair and Generic Montelukast |
| March 4, 2020 - FDA
Takes Rare Step to Ban Electrical Stimulation Devices for Self-Injurious
or Aggressive Behavior |
| March 3, 2020 - FDA
Informs Patients, Providers and Manufacturers About Potential Cybersecurity
Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy |
| March 2, 2020 - Coronavirus
(COVID-19) Update: FDA and CDC take action to increase access to respirators,
including N95s, for health care personnel |
| March 2, 2020 - FDA
Approves New Therapy for Patients with Previously Treated Multiple
Myeloma |
| February 29, 2020 - Coronavirus
(COVID-19) Update: FDA Issues New Policy to Help Expedite Availability
of Diagnostics |
| February 28, 2020 - FDA
Approves First Generic of Daraprim |
| February 27, 2020 - Coronavirus
(COVID-19) Supply Chain Update |
| February 27, 2020 - FDA
Reminds Patients that Devices Claiming to Clean, Disinfect or Sanitize
CPAP Machines Using Ozone Gas or UV Light Have Not Been FDA Authorized |
| February 25, 2020 - FDA
Takes New Steps to Increase the Safety of Laparoscopic Power Morcellators
when used in Gynecologic Surgeries |
| February 24, 2020 - Coronavirus
Update: FDA steps to ensure quality of foreign products |
| February 24, 2020 - FDA
approves first generic of ProAir HFA |
| February 21, 2020 - FDA
Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis
of Fragile X Syndrome |
| February 20, 2020 - FDA
Announces Collaborative Review of Scientific Evidence to Support Associations
Between Genetic Information and Specific Medications |
| February 20, 2020 - FDA
Works to Ensure Smooth Regulatory Transition of Insulin and Other
Biological Products |
| February 18, 2020 - FDA
Takes Action with Indian Government to Protect Consumers From Illicit
Medical Products |
| February 14, 2020 - FDA
Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch
Process |
| February 14, 2020 - FDA’s
Actions in Response to 2019 Novel Coronavirus at Home and Abroad |
| February 7, 2020 - FDA
Authorizes Marketing of First Cardiac Ultrasound Software That Uses
Artificial Intelligence to Guide User |
| February 7, 2020 - FDA
Expertise Advancing the Understanding of Intentional Genomic Alterations
in Animals |
| February 4, 2020 - FDA
Takes Significant Step in Coronavirus Response Efforts, Issues Emergency
Use Authorization for the First 2019 Novel Coronavirus Diagnostic |
| February 3, 2020 - FDA
and FTC Announce New Efforts to Further Deter Anti-Competitive Business
Practices, Support Competitive Market for Biological Products to Help
Americans |
| January 31, 2020 - FDA
approves first drug for treatment of peanut allergy for children |
| January 29, 2020 - FDA
launches mobile-friendly database with information on life-saving
HIV drugs as part of ongoing mission to empower the public through
increased access to information and data |
| January 28, 2020 - FDA
Continues Strong Support of Innovation in Development of Gene Therapy
Products |
| January 27, 2020 - FDA
Announces Key Actions to Advance Development of Novel Coronavirus
Medical Countermeasures |
| January 23, 2020 - FDA
approves first treatment option specifically for patients with epithelioid
sarcoma, a rare soft tissue cancer |
| January 23, 2020 - FDA
informs health care providers, facilities and patients about potential
cybersecurity vulnerabilities for certain GE Healthcare Clinical Information
Central Stations and Telemetry Servers |
| January 21, 2020 - FDA
approves first treatment for thyroid eye disease |
| January 16, 2020 - Statement
on quality issues with certain Cardinal Health surgical gowns and
packs |
| January 15, 2020 - Statement
on the Salinas-linked romaine lettuce E. coli O157:H7 outbreak and
status update on investigation |
| January 13, 2020 - Michigan-based
food manufacturer agrees to stop production after repeated food safety
violations |
| January 9, 2020 - FDA
approves the first targeted therapy to treat a rare mutation in patients
with gastrointestinal stromal tumors |
| January 9, 2020 - FDA,
USDA and EPA announce joint platform to streamline information about
agricultural biotechnology products |
| January 2, 2020 - FDA
finalizes enforcement policy on unauthorized flavored cartridge-based
e-cigarettes that appeal to children, including fruit and mint |
For links to the full articles and the most up to date
FDA headlines, see the FDA
Medical Device News page.
| December 30, 2020
Updated Emergency Use Authorizations
- COVID-19
Coronavirus Real Time PCR Kit (Jiangsu Bioperfectus Technologies
Co., Ltd.)
- Biomeme
SARS-CoV-2 Real-Time RT-PCR Test (Biomeme, Inc.)
- Ellume
COVID-19 Home Test (Ellume Limited)
|
|
December 29, 2020
Product
Labeling for Laparoscopic Power Morcellators - Guidance for Industry
and Food and Drug Administration Staff
UPDATE:
Perform Only Contained Morcellation When Laparoscopic Power Morcellation
Is Appropriate: FDA Safety Communication
Laparoscopic
Power Morcellators (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190035
and DEN200016 added)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- January 6, 2021
COVID-19
Tests and Collection Kits Authorized by the FDA in 2020: Infographic
Center
for Devices and Radiological Health's Response to Coronavirus (COVID-19):
Infographic (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
Federal
Register: Requests for Nominations: Technical Electronic Product
Radiation Safety Standards Committee; Voting Members
Federal
Register: Guidance: Product Labeling for Laparoscopic Power Morcellators
|
|
December 28, 2020
New Emergency Use Authorizations
- Xpert
Xpress SARS-CoV-2 DoD (Cepheid)
Updated Emergency Use Authorizations
- SARS-CoV-2
Fluorescent PCR Kit (Maccura Biotechnology (USA) LLC)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
| December 23, 2020
New Emergency Use Authorizations
- Solana
SARS-CoV-2 Assay (Quidel Corporation)
- Simoa
Semi-Quantitative SARS-CoV-2 IgG Antibody Test (Quanterix Corporation)
Updated Emergency Use Authorizations
- Xpert
Omni SARS-CoV-2 (Cepheid)
- BioFire
Respiratory Panel 2.1-EZ (RP2.1-EZ) (BioFire Diagnostics, LLC)
- EmpowerDX
At-Home COVID-19 PCR Test Kit (Clinical Enterprise, Inc.)
- Ellume
COVID-19 Home Test (Ellume Limited)
- Alinity
m SARS-CoV-2 assay (Abbott Molecular Inc.)
Supplies
of Medical Devices for COVID-19: Frequently Asked Questions
Medical
Device Shortages During the COVID-19 Public Health Emergency (Updated)
Medical
Device Types to Help Determine Section 506J Notification Obligations
(Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Class
I Recall: Cook Medical Recalls Flexor Check-Flo Introducers and
Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device
Recently Approved Devices:
- MiniMed
770G System - P160017/S076
|
|
December 22, 2020
Re-issued Emergency Use Authorizations
- RightSign
COVID-19 IgG/IgM Rapid Test Cassette (Hangzhou Biotest Biotech Co.,
Ltd.)
Updated Emergency Use Authorizations
- QuickVue
SARS Antigen Test (Quidel Corporation)
- Verily
COVID-19 RT-PCR Test (Verily Life Sciences)
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- BioFire
Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Effects
of the COVID-19 Public Health Emergency on Formal Meetings and User
Fee Applications for Medical Devices - Questions and Answers (Revised)
- Guidance for Industry and Food and Drug Administration Staff
Presentation
and Transcript posted for Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - December 16, 2020
|
|
December 21, 2020
New Emergency Use Authorizations
- QuickVue
SARS Antigen Test (Quidel Corporation)
- ADVIA
Centaur IL6 assay (Siemens Healthcare Diagnostics Inc.)
- SCONE
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
|
| December 18, 2020
New Emergency Use Authorizations
- MatMaCorp
COVID-19 2SF Test (Materials and Machines Corporation of America
(DBA MatmaCorp, Inc.))
Re-issued Emergency Use Authorizations
- Verily
COVID-19 RT-PCR Test (Verily Life Sciences)
- CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Clinical Research Sequencing Platform (CRSP), LLC at the Broad
Institute of MIT and Harvard)
- TRUPCR
SARS-CoV-2 Kit (3B Blackbio Biotech India Ltd., a subsidiary of
Kilpest India Ltd.)
Updated Emergency Use Authorizations
- BioCore
2019-nCoV Real Time PCR Kit (BioCore Co., Ltd.)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200035
added)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
December 17, 2020
New Emergency Use Authorizations
- Aptima
SARS-CoV-2/Flu assay (Hologic, Inc.)
- Procedure
Mask with Earloops (Honeywell International Inc.)
Re-issued Emergency Use Authorizations
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
- BinaxNOW
COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
Updated Emergency Use Authorizations
- Ellume
COVID-19 Home Test (Ellume Limited)
Presentation
and Transcript posted for Webinar Series - Respirators and Other
Personal Protective Equipment (PPE) for Health Care Personnel Use
During the COVID-19 Pandemic - December 8, 2020
Presentation
and Transcript posted for Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - December 9, 2020
Consumer
Information on: FoundationOne Liquid CDx - P200016
4th
Q FY2020 MDUFA IV Performance Report
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
|
|
December 16, 2020
New Emergency Use Authorizations
- GENETWORx
Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
- PacificDx
Covid-19 Test (ResearchDx, Inc., DBA Pacific Diagnostics)
- ACON
SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories, Inc.)
- BinaxNOW
COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
Re-issued Emergency Authorizations
- Phosphorus
COVID-19 RT-qPCR Test (Phosphorus Diagnostics LLC)
Updated Emergency Use Authorizations
- cobas
SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
News
Release: Coronavirus (COVID-19) Update: FDA Issues New Authorization
for the BinaxNOW COVID-19 Ag Card Home Test
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
December 15, 2020
New Emergency Use Authorizations
- Ellume
COVID-19 Home Test (Ellume Limited)
Non-In
Vitro Diagnostic eSTAR (Updated)
In
Vitro Diagnostic eSTAR (Updated)
Consumer
Information on: Plasma Delipidation System (PDS-2™ System)
– H190001
Consumer
Information on: Sonalleve MR-HIFU – H190003
FAQs
on Viral Transport Media During COVID-19 (Updated)
Penumbra’s
Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology
Due to Increased Risk of Mortality and Serious Injury – Urgent
Letter to Health Care Providers
News
Release: Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test
as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19
|
|
December 14, 2020
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
| December 11, 2020
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
- cobas
SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the
cobas Liat System (Roche Molecular Systems, Inc.)
- DxTerity
SARS-CoV-2 RT-PCR Test (DxTerity Diagnostics, Inc.)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
December 10, 2020
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Spinal
Plating Systems - Performance Criteria for Safety and Performance
Based Pathway - Guidance for Industry and Food and Drug Administration
Staff
Orthopedic
Non-Spinal Metallic Bone Screws and Washers - Performance Criteria
for Safety and Performance Based Pathway - Guidance for Industry
and Food and Drug Administration Staff
Magnetic
Resonance (MR) Receive-only Coil - Performance Criteria for Safety
and Performance Based Pathway - Guidance for Industry and Food and
Drug Administration Staff
Safety
and Performance Based Pathway (Updated)
Progress
Tracker for Premarket Submissions
COVID-19
Test Uses: FAQs on Testing for SARS-CoV-2 (Updated)
COVID-19
Testing Supplies: FAQs on Testing for SARS-CoV-2 (Updated)
COVID-19
Test Settings: FAQs on Testing for SARS-CoV-2 (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Federal
Register: Guidance: Performance Criteria for Safety and Performance
Based Pathway
Federal
Register: Guidance: Electromagnetic Compatibility of Medical Devices
|
|
December 9, 2020
New Emergency Use Authorization
- Pixel
by LabCorp COVID-19 Test Home Collection Kit (Laboratory Corporation
of America (LabCorp))
Re-issued Emergency Use Authorization
- COVID-19
RT-PCR Test (Laboratory Corporation of America (LabCorp))
Updated Emergency Use Authorization
- Bio-Speedy
Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Ltd.)
- Bio-Rad
SARS-CoV-2 ddPCR Test (Bio-Rad Laboratories, Inc)
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- December 16, 2020
|
|
December 8, 2020
New Emergency Use Authorizations
- Clip
COVID Rapid Antigen Test (Luminostics, Inc.)
Re-issued Emergency Use Authorization
- BioCode
SARS-CoV-2 Assay (Applied BioCode, Inc.)
#168,
MedSun Newsletter, December 2020
November
2020 PMA Approval List
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
December 7, 2020
New Emergency Use Authorizations
- Ecolab's
Bioquell Technology System
Updated Emergency Use Authorizations
- BioFire
COVID-19 Test
- Rheonix
COVID-19 MDx Assay
- binx
health At-Home Nasal Swab COVID-19 Sample Collection Kit
EUA
Authorized Serology Test Performance (Updated)
ESSURE
Medical Device Reporting Variance Spreadsheets for September and
October 2020
Wear
Face Masks with No Metal During MRI Exams: FDA Safety Communication
Transcript
for October 27, 2020 Circulatory System Devices Panel of the Medical
Devices Advisory Committee Meeting
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190047
and DEN200029 added)
|
|
December 4, 2020
New Emergency Use Authorizaitons
- Quest
Diagnostics RC COVID-19+Flu RT-PCR
Updated Emergency Use Authorizations
- Face
Shields and Other Barrier EUAs
Enforcement
Policy for the Quality Standards of the Mammography Quality Standards
Act During the COVID-19 Public Health Emergency - Guidance for Mammography
Facilities, State MQSA Contract Partners, FDA-Approved MQSA Accreditation
Bodies, and Food and Drug Administration Staff
MQSA
Inspection Information Related to COVID-19 (Updated)
UPDATE:
The FDA Reminds Patients and Health Care Providers of the Importance
of At Least Yearly, Lifelong Follow-Up with Use of Endologix AFX
Endovascular AAA Graft Systems: FDA Safety Communication
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
December 3, 2020
Updated Emergency Use Authorizations
- SARS-CoV-2
IgG assay (Abbott Laboratories Inc.)
- LYHER
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal
Gold) (Hangzhou Laihe Biotech Co., Ltd.)
- DxTerity
SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
Re-issued Emergency Use Authorizations
- CDC
2019-nCoV Real-Time RT-PCR Diagnostic Panel (Centers for Disease
Control and Prevention (CDC))
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - December
8, 2020
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
December 2, 2020
Serology/Antibody
Tests: FAQs on Testing for SARS-CoV-2 (Updated)
COVID-19
Testing Supplies: FAQs on Testing for SARS-CoV-2 (Updated)
SARS-CoV-2
Reference Panel Comparative Data (Updated)
Transcript
for November 9, 2020 Ophthalmic Devices Panel of the Medical Devices
Advisory Committee
MQSA
National Statistics
COVID-19
Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
December 1, 2020
New Emergency Use Authorizations
- Innovita
2019-nCoV Ab Test (Colloidal Gold) (Innovita (Tangshan) Biological
Technology Co., Ltd.)
Updated Emergency Use Authorizations
- Infinity
BiologiX TaqPath SARS-CoV-2 Assay (Infinity BiologiX LLC)
- MassARRAY
SARS-CoV-2 Panel (Agena Bioscience, Inc.)
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Class
I Recall: Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion
Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ
Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown
Issues
Presentation
Slides added to Virtual Public Meeting - Medical Device User Fee
Amendments for Fiscal Years 2023 Through 2027
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
| November 30, 2020
New Emergency Use Authorizations
- Xpert
Omni SARS-CoV-2 (Cepheid)
- Elecsys
Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.)
- Terumo
Cardiovascular CAPIOX Emergency Bypass System
Re-issued Emergency Use Authorizations
- Quest
Diagnostics RC SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease,
Inc.)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
| November 27, 2020
New Emergency Use Authorizations
- COVID-SeroKlir,
Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit (Kantaro Biosciences,
LLC)
Re-issued Emergency Use Authorizations
- SARS-CoV-2
RT-PCR Assay (Stanford Health Care Clinical Virology Laboratory)
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
|
|
November 25, 2020
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Notifying
CDRH of a Permanent Discontinuance or Interruption in Manufacturing
of a Device Under Section 506J of the FD&C Act During the COVID-19
Public Health Emergency (Revised) - Guidance for Industry and Food
and Drug Administration Staff
Enforcement
Policy for Bioburden Reduction Systems Using Dry Heat to Support
Single-User Reuse of Certain Filtering Facepiece Respirators During
the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Guidance for Industry, Healthcare Organizations, Healthcare Personnel,
and Food and Drug Administration Staff
Bioburden
Reduction Systems Frequently Asked Questions
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
November 24, 2020
New Emergency Use Authorizations
- RapidRona
Self-Collection Kit (RapidRona, Inc.)
- Gravity
Diagnostics SARS-CoV-2 RT-PCR Assay (Gravity Diagnostics, LLC)
Re-Issued Emergency Use Authorizations
- Express
Gene 2019-nCoV RT-PCR Diagnostic Panel (Express Gene LLC, DBA: Express
Gene Molecular Diagnostics Laboratory)
Updated Emergency Use Authorizations
- Lucira
COVID-19 All-In-One Test Kit (Lucira Health, Inc.)
- cobas
SARS-CoV-2 (Roche Molecular Systems, Inc.)
- Influenza
SARS-CoV-2 (Flu SC2) Multiplex Assay (Centers for Disease Control
and Prevention (CDC))
- PhoenixDx
SARS-CoV-2 Multiplex (Trax Management Services Inc.)
- Linea
COVID-19 Assay Kit (Applied DNA Sciences, Inc.)
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
ASCA-Recognized
Accreditation Bodies
Face
Masks, Including Surgical Masks, and Respirators for COVID-19 (Updated)
Presentations
and Transcripts added to Virtual Town Hall Series - Coronavirus
(COVID-19) Test Development and Validation - November 4, 2020 and
November 18, 2020
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Serology
Template for Test Developers (Updated)
Home
Specimen Collection Serology Template for Fingerstick Dried Blood
Spot (New)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190029
and DEN200043 added)
|
|
November 23, 2020
New Emergency Use Authorizations
- PortPatch
(MRC Global, LLC)
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
Transcript
for October 22, 2020 Patient Engagement Advisory Committee Meeting
Presentation
and Transcript added to Digital Health Center of Excellence Listening
Session #2 - November 12, 2020
Consumer
Information on: FoundationOne® CDx - P170019/S017
Consumer
Information on: Oncomine™ Dx Target Test - P160045/S019
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
| November 20, 2020
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
November 19, 2020
Federal
Register: Authorization of Emergency Use of Certain Medical Devices
during COVID-19
|
|
November 18, 2020
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- December 2, 2020
Digital
Health Reports (Updated)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Removal
Lists of Tests that Should No Longer Be Used and/or Distributed
for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
|
|
November 17, 2020
Updated Emergency Use Authorizations
- Infinity
BiologiX TaqPath SARS-CoV-2 Assay (Infinity BiologiX LLC)
New Emergency Use Authorizations
- Lucira
COVID-19 All-In-One Test Kit (Lucira Health, Inc.)
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
FAQs
on Viral Transport Media During COVID-19
|
|
November 16, 2020
New Emergency Use Authorizations
- HA
PP02 (Hygiene Austria LP GmbH)
Electromagnetic
Compatibility (EMC) of Medical Devices - Draft Guidance for Industry
and Food and Drug Administration Staff
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200033
added)
FAQs
on Testing for SARS-CoV-2 (Updated)
Federal
Register: Guidance: Electromagnetic Compatibility of Medical Devices
|
| November 13, 2020
Updated Emergency Use Authorizations
- SARS-CoV-2
Test Kit (Real-time PCR) (Xiamen Zeesan Biotech Co., Ltd.)
- Quest
SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.)
- BIOTIME
SARS-CoV-2 IgG/IgM Rapid Qualitative Test (Xiamen Biotime Biotechnology
Co., Ltd.)
- Orawell
IgM/IgG Rapid Test (Jiangsu Well Biotech Co., Ltd.)
Presentation
and Transcript added to Webinar - Accreditation Scheme for Conformity
Assessment (ASCA) Pilot Program - Final Guidances - October 22,
2020
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - December
8, 2020
Catalog
of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
Consumer
Information on: Zilver Vena Venous Self-Expanding Stent - P200023
|
|
November 12, 2020
EUA
Authorized Serology Test Performance (Updated)
Consumer
Information on: Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter
Heart Valve System - P140031/S112
Consumer
Information on: Ranger Paclitaxel-Coated PTA Balloon Catheter -
P190019 - P140031/S112
Cook
Medical Recalls Fixed Core Wire Guides, Due to Device Damage from
a Manufacturing Error
24
Hour Summary for November 9, 2020 Ophthalmic Devices Panel of the
Medical Devices Advisory Committee
|
|
November 10, 2020
Presentations
posted for November 9, 2020 Ophthalmic Devices Panel of the Medical
Devices Advisory Committee
Consumer
Information on: Abre Venous Self-expanding Stent System - P200026
|
|
November 9, 2020
New Emergency Use Authorizations
- Medimask
MM-001 (Brands Unlimited S.A. de C.V.)
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
- Advanta
Dx SARS-CoV-2 RT-PCR Assay (Fluidigm Corporation)
- SARS-COV-2
R-GENE (BioMérieux SA)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - October 28, 2020
Consumer
Information on: FoundationOne Liquid CDx - P190032
Press
Release: FDA Permits Marketing of New Device Designed to Reduce
Sleep Disturbance Related to Nightmares in Certain Adults
Regulatory
Considerations for Microneedling Products - Guidance for Industry
and Food and Drug Administration Staff
Aesthetic
(Cosmetic) Devices (Updated)
Microneedling
Devices
Class
I Recall: Stryker Neurovascular Recalls Trevo XP ProVue Retriever
Due to Core Wire That May Break or Separate During Use
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200001
added)
FAQs
on Testing for SARS-CoV-2 (Updated)
Federal
Register: Guidance: Regulatory Considerations for Microneedling
Products
|
| November 6, 2020
New Emergency Use Authorizations
- cPass
SARS-CoV-2 Neutralization Antibody Detection Kit (GenScript USA
Inc.)
Updated Emergency Use Authorizations
- Umbrella
EUA for Surgical Masks - Appendix A: Authorized Surgical Masks
Meeting
materials posted for November 9, 2020 Ophthalmic Devices Panel of
the Medical Devices Advisory Committee
Process
to Request a Review of FDA's Decision Not to Issue Certain Export
Certificates for Devices - Guidance for Industry and Food and Drug
Administration Staff
Devices
not Exported from the United States
Exporting
Medical Devices Frequently Asked Questions (FAQs) (Updated)
Importing
and Exporting Medical Devices (Updated)
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
November 5, 2020
MedSun
Newsletter, November 2020
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- November 18, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
November 4, 2020
Updated Emergency Use Authorizations
- Umbrella
EUA for Surgical Masks - Appendix A: Authorized Surgical Masks
- COVID-19
RT-PCR Test (Laboratory Corporation of America (LabCorp))
- EURORealTime
SARS-Cov-2 (Euroimmun US, Inc.)
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Devices; Device Tracking
|
|
November 3, 2020
Re-Issued Emergency Use Authorizations
- Color
SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Genomics, Inc.)
Updated Emergency Use Authorizations
- PerkinElmer
New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
- Allplex
2019-nCoV Assay (Seegene, Inc.)
Revised Emergency Use Authorizations
- Dimension
Vista SARS-CoV-2 Total antibody assay (COV2T) (Siemens Healthcare
Diagnostics Inc.)
- Dimension
EXL SARS-CoV-2 Total antibody assay (CV2T) (Siemens Healthcare Diagnostics
Inc.)
- CareStart
COVID-19 IgM/IgG (Access Bio, Inc.)
- Wantai
SARS-CoV-2 RT-PCR Kit (Beijing Wantai Biological Pharmacy Enterprise
Co., Ltd.)
Class
I Recall: Medtronic Recalls Rashkind Balloon Septostomy Catheters
for Quality Issues
Potential
for False Positive Results with Antigen Tests for Rapid Detection
of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care
Providers
|
|
November 2, 2020
New Emergency Use Authorizations
- Q-Plex
SARS-CoV-2 Human IgG (4 Plex) (Quansys Biosciences, Inc.)
Re-Issued Emergency Use Authorizations
- PerkinElmer
New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
Updated Emergency Use Authorizations
- VITROS
Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack (Ortho
Clinical Diagnostics, Inc.)
- BIOTIME
SARS-CoV-2 IgG/IgM Rapid Qualitative Test (Xiamen Biotime Biotechnology
Co., Ltd.)
- Platelia
SARS-CoV-2 Total Ab assay (Bio-Rad Laboratories, Inc.)
MQSA
National Statistics
FAQs
on Testing for SARS-CoV-2 (Updated)
|
| October 30, 2020
New Emergency Use Authorizations
- ORAcollect·RNA
OR-100 and ORAcollect·RNA ORE-100 saliva collection devices
(DNA Genotek Inc.)
Re-Issued Emergency Use Authorizations
- OMNIgene·ORAL
OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices
(DNA Genotek Inc.)
Updated Emergency Use Authorizations
- NxTAG
CoV Extended Panel Assay (Luminex Molecular Diagnostics, Inc.)
- ARIES
SARS-CoV-2 Assay (Luminex Corporation)
- LetsGetChecked
Coronavirus (COVID-19) Test (PrivaPath Diagnostics, Inc.)
- Illumina
COVIDSeq Test (Illumina, Inc.)
- cobas
SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
- Aptima
SARS-CoV-2 assay (Hologic, Inc.)
Consumer
Update: Pulse Oximeters and Oxygen Concentrators: What to Know About
At-Home Oxygen Therapy
FDA
Publishes List of Essential Medicines, Medical Countermeasures,
Critical Inputs Required by Executive Order
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- November 4, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
October 29, 2020
Updated Emergency Use Authorizations
- Umbrella
EUA for Surgical Masks - Appendix A: Authorized Surgical Masks
Presentation
and Transcript added to Webinar - Digital Health Center of Excellence
Listening Session #1 - October 19, 2020
24
Hour Summary for October 27, 2020 Circulatory System Devices Panel
of the Medical Devices Advisory Committee Meeting
Virtual
Public Meeting - FDA's Communications About the Safety of Medical
Devices - November 17, 2020
Consumer
Information on: Simplify Cervical Artificial Disc - P200022
Presentations
added to Public Meeting - Using Patient Preference Information in
Medical Device Regulatory Decisions: Benefit-Risk and Beyond - September
29, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
October 28, 2020
Enforcement
Policy for Non-Invasive Remote Monitoring Devices Used to Support
Patient Monitoring During the Coronavirus Disease 2019 (COVID-19)
Public Health Emergency (Revised) - Guidance for Industry and Food
and Drug Administration Staff
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
October 27, 2020
New Emergency Use Authorizations
- MassARRAY
SARS-CoV-2 Panel (Agena Bioscience, Inc.)
Re-Issued Emergency Use Authorizations
- QuantiVirus
SARS-CoV-2 Test Kit (DiaCarta, Inc.)
Updated Emergency Use Authorizations
- BIOTIME
SARS-CoV-2 IgG/IgM Rapid Qualitative Test (Xiamen Biotime Biotechnology
Co., Ltd.)
- Helix
COVID-19 Test (Helix OpCo LLC)
24
Hour Summary and Presentations posted for October 22, 2020 Patient
Engagement Advisory Committee Meeting
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200026
added)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - October 21, 2020
Automated
External Defibrillators (AEDs) (Updated)
Necessary
Automated External Defibrillator Accessories: Policy Regarding Compliance
Date - Guidance for Industry, Stakeholders, Health Care Professionals,
and Food and Drug Administration Staff
Federal
Register: Necessary Automated External Defibrillator Accessories:
Policy Regarding Compliance Date
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
October 26, 2020
New Emergency Use Authorizations
- Sampinute
COVID-19 Antigen MIA (Celltrion USA, Inc.)
Updated Emergency Use Authorizations
- Bio-Speedy
Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Ltd.)
- Helix
COVID-19 Test (Helix OpCo LLC)
- CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Clinical Research Sequencing Platform (CRSP), LLC at the Broad
Institute of MIT and Harvard)
- VITROS
Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack (Ortho-Clinical
Diagnostics, Inc.)
- Elecsys
Anti-SARS-CoV-2 (Roche Diagnostics)
Antigen
Template for Test Developers (Updated)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
| October 23, 2020
Meeting
materials posted for October 27, 2020 Circulatory System Devices
Panel of the Medical Devices Advisory Committee
Presentation
and Transcript posted for Protective Barrier Enclosure Emergency
Use Authorizations (EUAs) Webinar - October 13, 2020
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - October
27, 2020
|
|
October 22, 2020
New Emergency Use Authorizations
- binx
health At-Home Nasal Swab COVID-19 Sample Collection Kit (binx health,
Inc.)
Re-Issued Emergency Use Authorizations
- Wren
Laboratories COVID-19 PCR Test (Wren Laboratories LLC)
- P23
Labs TaqPath SARS-CoV-2 Assay (P23 Labs, LLC.)
Updated Emergency Use Authorizations
- T2SARS-CoV-2
Panel (T2 Biosystems, Inc.)
- BioCode
SARS-CoV-2 Assay (Applied BioCode, Inc.)
Cybersecurity
(Updated)
National
Cybersecurity Awareness Month VideoExternal Link Disclaimer
Engaging
Patients Is Part of CDRH Culture: Videos
Presentation
and Transcript posted for Recognition and Withdrawal of Voluntary
Consensus Standards Final Guidance Webinar - October 15, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
October 21, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
October 20, 2020
Updated Emergency Use Authorizations
- Genetrack
SARS-CoV-2 Molecular Assay (Genetrack Biolabs, Inc.)
- LIAISON
SARS-CoV-2 S1/S2 IgG (DiaSorin Inc.)
- Biohit
SARS-CoV-2 IgM/IgG Antibody Test Kit (Biohit Healthcare (Hefei)
Co. Ltd.)
- Face
Shields and Other Barrier EUAs (Updated)
Medical
Device Development Tools (MDDT)
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
October 19, 2020
New Emergency Use Authorizations
- High
Flow Humidifier (HFT-150) (Invent Medical Corporation)
Meeting
Materials posted for October 22, 2020: Patient Engagement Advisory
Committee
Communicating
Cybersecurity Vulnerabilities to Patients: Considerations for a
Framework
Presentations
and Transcripts added to Virtual Town Hall Series - Coronavirus
(COVID-19) Test Development and Validation - October 7 and 14, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
|
| October 16, 2020
New Emergency Use Authorizations
- OMNIgene·ORAL
OM-505 and OME-505 (OMNIgene·ORAL) saliva collection devices
(DNA Genotek Inc)
- LumiraDx
SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
- EmpowerDX
At-Home COVID-19 PCR Test Kit (Clinical Enterprise, Inc.)
Updated Emergency Use Authorizations
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- SDNA-1000
Saliva Collection Device (Spectrum Solutions LLC)
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
- Appendix
A: Authorized Surgical Masks
Re-Issued Emergency Use Authorizations
- cobas
SARS-CoV-2 (Roche Molecular Systems, Inc.)
- Viracor
SARS-CoV-2 assay (Viracor Eurofins Clinical Diagnostics)
FAQs
on Testing for SARS-CoV-2 (Update)
CDRH
Proposed Guidances for Fiscal Year 2021 (FY 2021)
CDRH
Proposed Guidance Development (Updated)
Third
Party Performance Metrics - FY20, Q4
Federal
Register: Website Location of Center for Devices and Radiological
Health Fiscal Year 2021 Proposed Guidance Development
|
|
October 15, 2020
Updated Emergency Use Authorizations
- Personal
Protective Equipment EUAs (Updated)
Problems
Reported with Essure - New Variance Report
Medical
Device User Fee Amendments 2023 (MDUFA V)
MDUFA
IV and Beyond – Video Reports
Virtual
Public Meeting - Medical Device User Fee Amendments for Fiscal Years
2023 Through 2027
FAQs
on Viral Transport Media During COVID-19 (Updated)
FAQs
on Testing for SARS-CoV-2 (Update)
Certain
Filtering Facepiece Respirators from China May Not Provide Adequate
Respiratory Protection - Letter to Health Care Providers (Updated)
Federal
Register: Requests for Nominations: Public Advisory Panels of the
Medical Devices Advisory Committee
|
|
October 14, 2020
Select
Updates for Biocompatibility of Certain Devices in Contact with
Intact Skin - Draft Guidance for Industry and Food and Drug Administration
Staff
Technical
Considerations for Non-Clinical Assessment of Medical Devices Containing
Nitinol - Guidance for Industry and Food and Drug Administration
Staff
Consumer
Information on: LIAISON® XL MUREX HBc IgM, LIAISON® MUREX
Control HBc IgM – P180045
Consumer
Information on: LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX
Control HBeAg
Presentation
and Transcript posted for Respirators and Other PPE for Health Care
Personnel Use Webinar - September 29, 2020
EUA
Authorized Serology Test Performance (Updated)
Federal
Register: Guidance - Technical Considerations for Non-Clinical Assessment
of Medical Devices Containing Nitinol
Federal
Register: Guidance - Select Updates for Biocompatibility of Certain
Devices in Contact with Intact Skin
Federal
Register: Requests for Nominations - Voting Members on Public Advisory
Panels or Committees; Device Good Manufacturing Practice Advisory
Committee and the Medical Devices Advisory Committee
|
|
October 13, 2020
New Emergency Use Authorizations
- AdviseDx
SARS-CoV-2 IgM (Abbott Laboratories Inc.)
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- CareStart
COVID-19 Antigen test (Access Bio, Inc.)
FAQs
on Testing for SARS-CoV-2 (Update)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Enforcement
Policy for Modifications to FDA Cleared Molecular Influenza and
RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public
Health Emergency - Guidance for Industry and Food and Drug Administration
Staff
Consumer
Information on: LIAISON® XL MUREX anti-HBe, LIAISON® XL
MUREX Control anti-HBe
Consumer
Information on: Alinity m HBV – P200013
|
| October 9, 2020
New Emergency Use Authorizations
- ePlex
Respiratory Pathogen Panel 2 (GenMark Diagnostics, Inc.)
- SDNA-1000
Saliva Collection Device (Spectrum Solutions LLC)
- Access
SARS-CoV-2 IgM (Beckman Coulter, Inc.)
- Maverick
SARS-CoV-2 Multi-Antigen Serology Panel v2 (Genalyte, Inc.)
- CareStart
COVID-19 Antigen test (Access Bio, Inc.)
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- UCLA
SwabSeq COVID-19 Diagnostic Platform (University of California,
Los Angeles (UCLA))
EUA
Authorized Serology Test Performance (Updated)
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - October
13, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
October 8, 2020
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
October 7, 2020
New Emergency Use Authorizations
- AQ-TOP
COVID-19 Rapid Detection Kit PLUS (SEASUN BIOMATERIALS, Inc.)
- UCLA
SwabSeq COVID-19 Diagnostic Platform (University of California,
Los Angeles (UCLA))
- ZEUS
ELISA SARS-CoV-2 IgG Test System (ZEUS Scientific, Inc.)
Re-issued Emergency Use Authorization
- Aptima
SARS-CoV-2 assay (Hologic, Inc.)
Updated Emergency Use Authorizations
- MobileDetect
Bio BCC19 (MD-Bio BCC19) Test Kit (Detectachem Inc.)
- OmniPATH
COVID-19 Total Antibody ELISA Test (Thermo Fisher Scientific)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
Recommendations
on Providing Clear Instructions to Patients Who Self-Collect an
Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2
Testing - Letter to Health Care Providers
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Presentation
and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19)
Test Development and Validation - September 30, 2020
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- October 14, 2020
Press
Release: FDA Issues Warning Letter to Battelle Memorial Institute,
a Manufacturer of an Authorized Decontamination System Used on Respirators
Clinical
Outcome Assessments (COAs) in Medical Device Decision Making (Updated)
Patient
Preference Information (PPI) in Medical Device Decision-Making (Updated)
List
of Patient Preference-Sensitive Priority Areas (Updated)
|
|
October 6, 2020
Cybersecurity
(Updated)
Electronic
Delivery of Premarket Submissions Pilot
|
|
October 5, 2020
New Emergency Use Authorizations
- UMass
Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel (UMass
Memorial Medical Center)
- BioFire
Respiratory Panel 2.1-EZ (RP2.1-EZ) (BioFire Diagnostics, LLC)
- OmniPATH
COVID-19 Total Antibody ELISA Test (Thermo Fisher Scientific)
- Sofia
2 Flu + SARS Antigen FIA (Quidel Corporation)
Re-issued Emergency Use Authorizations
- Cuur
Diagnostics SARS-CoV-2 Molecular Assay (Cuur Diagnostics)
- MobileDetect
Bio BCC19 (MD-Bio BCC19) Test Kit (Detectachem Inc.)
Updated Emergency Use Authorizations
- Smart
Detect SARS-CoV-2 rRT-PCR Kit (InBios International, Inc)
FAQs
on Testing for SARS-CoV-2 (Updated)
NOTICE
OF MEETING POSTPONEMENT: October 7, 2020 Circulatory System Devices
Panel of the Medical Devices Advisory Committee
Medical
Device Reporting (MDR): How to Report Medical Device Problems (Updated)
|
|
October 2, 2020
Federal
Register: Circulatory System Devices Panel of the Medical Devices
Advisory Committee
Class
I Recall: Becton Dickinson CareFusion 303, Inc. Recalls Alaris™
System Pump Module and Pump Module Door Assembly Replacement Kits
Due to the Potential for Stuck or Unresponsive Keys
September
2020 PMA Approval List
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200002
added)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
October 1, 2020
New Emergency Use Authorizations
- Alimetrix
SARS-CoV-2 RT-PCR Assay (Alimetrix, Inc.)
- iC
SARS-CoV2 Test (Tempus Labs, Inc.)
- Access
IL-6 (Beckman Coulter, Inc.)
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- Xpert
Xpress SARS-CoV-2/Flu/RSV (Cepheid)
MQSA
National Statistics
Virtual
Town Hall Series - Coronavirus (COVID-19) Test Development and Validation
- October 7, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
Presentation
and Transcript added to Safety and Performance Based Pathway Criteria
for Certain Device Types Final Guidances Webinar - September 24,
2020
|
| September 30, 2020
LIAISON
XL MUREX HBsAg Confirmatory test, LIAISON® XL MUREX Control
HBsAg, LIAISON® XL MUREX Qual HBsAg - P190017
SARS-CoV-2
Reference Panel Comparative Data (Updated)
Potential
Risk of Infection during Cardiac Surgery When Using the CardioQuip
Modular Cooler-Heater Device – Letter to Health Care Providers
Presentation
and Transcript added to Immediately in Effect Guidance on Coronavirus
(COVID-19) Diagnostic Tests Webinar - September 23, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
New Emergency Use Authorizations
- Aeon
Global Health SARS-CoV-2 Assay (Aeon Global Health)
- CentoSure
SARS-CoV-2 RT-PCR Assay (CENTOGENE US, LLC)
- Akron
Children’s Hospital SARS-CoV-2 Assay (Akron Children’s
Hospital)
- SARS-CoV-2
MassArray Test (National Jewish Health)
- DiaSorin
LIAISON SARS-CoV-2 IgM Assay (DiaSorin, Inc.)
- FREND
COVID-19 total Ab (NanoEntek America, Inc.)
- Nirmidas
COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit (Nirmidas Biotech,
Inc.)
|
|
September 29, 2020
Center
for Devices and Radiological Health's Response to Coronavirus (COVID-19):
Infographic
Dental
Amalgam Fillings (Updated)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
September 28, 2020
New Emergency Use Authorizations
- Genetrack
SARS-CoV-2 Molecular Assay (Genetrack Biolabs, Inc.)
- MosaiQ
COVID-19 Antibody Magazine (Quotient Suisse SA)
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
- OraRisk
COVID-19 RT-PCR (Access Genetics, LLC)
- AvellinoCoV2
test (Avellino Lab USA, Inc.)
- PerkinElmer
New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
Breast
Implants - Certain Labeling Recommendations to Improve Patient Communication
- Guidance for Industry and Food and Drug Administration Staff
Saline,
Silicone Gel, and Alternative Breast Implants - Guidance for Industry
and FDA Staff
Electronic
Product Radiation Control (EPRC) Variance Application Process| FDA
Federal
Register: Blood Glucose Monitoring Test Systems for Prescription
Point-of-Care Use
Federal
Register: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter
Use
Federal
Register: Breast Implants; Certain Labeling Recommendations to Improve
Patient Communication
|
| September 25, 2020
New Emergency Use Authorizations
- Xpert
Xpress SARS-CoV-2 (Cepheid)
- COVIAGE
(Duke University)
- COViage
(Dascena, Inc.)
Re-issued Emergency Use Authorization
- Panther
Fusion SARS-CoV-2 Assay (Hologic, Inc.)
Updated Emergency Use Authorizations
- cobas
SARS-CoV-2 & Influenza A/B Nucleic Acid Test (Roche Molecular
Systems, Inc.)
- AvellinoCoV2
test (Avellino Lab USA, Inc.)
- Acupath
COVID-19 Real-Time (RT-PCR) Assay (Acupath Laboratories, Inc.)
- BD
SARS-CoV-2Reagents for BD MAX System (Becton, Dickinson & Company)
- Assure
COVID-19 IgG/IgM Rapid Test Device (Assure Tech. (Hangzhou Co.,
Ltd))
Mammography
Problems at Allison Breast Center at Monument Radiology in Richmond,
Virginia: FDA Safety Communication
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
September 24, 2020
New Emergency Use Authorizations
- Clear
Dx SARS-CoV-2 Test (Clear Labs, Inc.)
- Orawell
IgM/IgG Rapid Test (Jiangsu Well Biotech Co., Ltd.)
Updated Emergency Use Authorization
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
Re-Issued Emergency Use Authorization
- BD
SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson & Company)
The
Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Guidance for Industry, Accreditation Bodies, Testing Laboratories,
and Food and Drug Administration Staff
Basic
Safety and Essential Performance of Medical Electrical Equipment,
Medical Electrical Systems, and Laboratory Medical Equipment - Standards
Specific Information for the Accreditation Scheme for Conformity
Assessment (ASCA) Pilot Program - Guidance for Industry, Accreditation
Bodies, Testing Laboratories, and Food and Drug Administration Staff
Biocompatibility
Testing of Medical Devices - Standards Specific Information for
the Accreditation Scheme for Conformity Assessment (ASCA) Pilot
Program - Guidance for Industry, Accreditation Bodies, Testing Laboratories,
and Food and Drug Administration Staff
Webinar
- Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
- Final Guidances - October 22, 2020
Accreditation
Scheme for Conformity Assessment (ASCA) (Updated)
Webinar
Series - Respirators and Other Personal Protective Equipment (PPE)
for Health Care Personnel Use During the COVID-19 Pandemic - September
29, 2020
Recommendations
About the Use of Dental Amalgam in Certain High-Risk Populations:
FDA Safety Communication
- Information
for Patients About Dental Amalgam Fillings
Presentation
and Transcript added to Gowns and Other Apparel for Use by Health
Care Personnel in COVID-19 Pandemic Webinar - September 15, 2020
Federal
Register: The Accreditation Scheme for Conformity Assessment Pilot
Program
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
September 23, 2020
New Emergency Use Authorizations
- Clarifi
COVID-19 Test Kit (Quadrant Biosciences Inc.)
- ViroKey
SARS-CoV-2 RT-PCR Test v2.0 (Vela Operations Singapore Pte. Ltd.)
Updated Emergency Use Authorizations
- ScienCell
SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit
(ScienCell Research Laboratories)
- BioGX
SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson & Company
(BD))
- SARS-CoV-2
PCR Test (Centers for Disease Control and Prevention (CDC))
- Color
Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Genomics, Inc.)
- LabGun
COVID-19 RT-PCR Kit (LabGenomics Co., Ltd.)
- Assure
COVID-19 IgG/IgM Rapid Test Device (Assure Tech. - Hangzhou Co.,
Ltd)
Revoked Emergency Use Authorizations
- Umbrella
of Infusion Pumps and Infusion Pump Accessories
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
September 22, 2020
New Emergency Use Authorizations
- KimForest
SARS-CoV-2 Detection Kit v1 (KimForest Enterprise Co., Ltd.)
Updated Emergency Use Authorizations
- Lilly
SARS-CoV-2 Assay (Eli Lilly and Company)
- SARS-CoV-2
PCR Test (Diatherix Eurofins Laboratory)
Digital
Health Center of Excellence
Webinar
- Digital Health Center of Excellence Listening Session #1 - October
19, 2020
Webinar
- Digital Health Center of Excellence Listening Session #2 - November
12, 2020
FDA
Clarifies Types of Evidence Relevant to Determining the “Intended
Use” of FDA-Regulated Products
Network
of Experts Program: Connecting the FDA with External Expertise
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
September 21, 2020
Updated Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
- Bio-Rad
SARS-CoV-2 ddPCR Test (Bio-Rad Laboratories, Inc.)
- Infinity
BiologiX TaqPath SARS-CoV-2 Assay (Infinity BiologiX LLC)
- COVID-19
RT-PCR Test - Laboratory Corporation of America (LabCorp)
- Ethos
Laboratories SARS-CoV-2 MALDI-TOF Assay (Ethos Laboratories)
- SARS-CoV-2
IgG assay (Abbott Laboratories Inc.)
New Emergency Use Authorizations
- GK
ACCU-RIGHT SARS-CoV-2 RT-PCR KIT (GK Pharmaceuticals Contract Manufacturing
Operations)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190032,
DEN190039, DEN200010 added)
Exemptions,
Variances, and Alternate Forms of Adverse Event Reporting for Medical
Devices
FAQs
on Testing for SARS-CoV-2 (Updated)
|
| September 18, 2020
24
Hour Summaries posted for September 8-9, 2020 Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices Advisory Committee Meeting
Re-Issued Emergency Use Authorization
- ID
NOW COVID-19 (Abbott Diagnostics Scarborough, Inc.)
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
September 17, 2020
New Emergency Use Authorizations
- Visby
Medical COVID-19 (Visby Medical, Inc.)
- MAGLUMI
2019-nCoV IgM/IgG (Shenzhen New Industries Biomedical Engineering
Co., Ltd.)
Virtual
Public Meeting - FDA's Communications About the Safety of Medical
Devices - November 17, 2020
Presentation
and Transcript added to Webinar - Multiple Function Device Products:
Policy and Considerations - September 10, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
Federal
Register: Microbiology Devices: Reclassification of Cytomegalovirus
Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant
Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic
Acid Tests for Transplant Patient Management
|
|
September 16, 2020
Meeting
Notice: October 27, 2020 Circulatory System Devices Panel of the
Medical Devices Advisory Committee
Class
I Recall: Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris™
Syringe and Alaris™ PCA Modules Due to Potential Incorrect
Display of Syringe Types and/or Sizes
Virtual
Town Hall Series - Immediately in Effect Guidance on Coronavirus
(COVID-19) Diagnostic Tests - September 23, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Update)
|
|
September 15, 2020
New Emergency Use Authorizations
- cobas
SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the
cobas Liat System (Roche Molecular Systems, Inc.)
Updated Emergency Use Authorizations
- TRIPLEX
CII-SARS-CoV-2 rRT-PCR TEST (Columbia University Laboratory of Personalized
Genomic Medicine) (EUA Summary, Letter Granting EUA Revision(s))
- Aptima
SARS-CoV-2 assay (Hologic, Inc.) (HCP, Patient, IFU, Letter Granting
EUA Revision(s))
Re-Issue Emergency Use Authorizations
- Color
COVID-19 Test Unmonitored Collection Kit (Color Genomics, Inc.)
Problems
Reported with Essure - New Variance Report
FAQs
on Testing for SARS-CoV-2 (Updated)
SARS-CoV-2
Reference Panel Comparative Data
Federal
Register: Circulatory System Devices Panel of the Medical Devices
Advisory Committee
|
|
September 14, 2020
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
Consumer
Information on: Edwards SAPIEN 3 Transcatheter Heart Valve System
with Edwards Commander Delivery System - P200015
Recognition
and Withdrawal of Voluntary Consensus Standards - Guidance for Industry
and Food and Drug Administration Staff
Webinar
- Recognition and Withdrawal of Voluntary Consensus Standards -
Final Guidance - October 15, 2020
Digital
Health Software Precertification (Pre-Cert) Program (Updated)
Class
I Recall: Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™
System PC Unit and PC Unit Front Case Keypad Replacement Kits Due
to Risk of Stuck or Unresponsive Keys
Class
I Recall: Becton Dickinson (BD) CareFusion 303 Recalls Alaris System
Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose
or Missing Battery Screws and A Broken Upper and Lower Hinge Posts
and Membrane Frame
3rd
Quarter FY 2020 MDUFA IV Performance Report
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Federal
Register: Recognition and Withdrawal of Voluntary Consensus Standards
|
| September 11, 2020
Mammography
Facility Adverse Event and Action Report - September 11, 2020: SBPH-Saint
Bernard Parish Hospital/Ochsner
Consumer
Information on: VENTANA HER2 Dual ISH DNA Probe Cocktail - P190031
EUA
Authorized Serology Test Performance (Updated)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
September 10, 2020
Presentation
and Transcript added to Regulatory Overview for Developers and Sponsors
of Neurological and Physical Medicine Devices: An Introduction to
the De Novo Pathway Webinar
Webinar
Series - Gowns and Other Apparel for Use by Health Care Personnel
in COVID-19 Pandemic - September 15, 2020
New Emergency Use Authorizations
- Wantai
SARS-CoV-2 RT-PCR Kit (Beijing Wantai Biological Pharmacy Enterprise
Co., Ltd.)
- BioCheck
SARS-CoV-2 IgM Antibody Test Kit (BioCheck, Inc.)
- BioCheck
SARS-CoV-2 IgG Antibody Test Kit (BioCheck, Inc.)
Re-issued Emergency Use Authorizations
- KPMAS
COVID-19 Test (Kaiser Permanente Mid-Atlantic States)
Updated Emergency Use Authorizations
- Verily
COVID-19 RT-PCR Test (Verily Life Sciences) (EUA Summary)
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
September 9, 2020
New Emergency Use Authorizations
- Verily
COVID-19 RT-PCR Test (Verily Life Sciences)
Updated Emergency Use Authorizations
- cobas
SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.) (IFU)
FAQs
on Testing for SARS-CoV-2 (Updated)
FDA
Reminds Users about the Importance of Following Instructions for
the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices:
FDA Safety Communication
|
|
September 8, 2020
New Emergency Use Authorizations
- qSanger-COVID-19
Assay (BillionToOne, Inc.)
Updated Emergency Use Authorizations
- Everlywell
COVID-19 Test Home Collection Kit (Everlywell, Inc.) (EUA Summary,
Letter Granting EUA Revision(s))
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Consumer
Information on: SYNERGY Everolimus-Eluting Platinum Chromium Coronary
Stent System (Monorail and Over-The-Wire) – P15003/S058
Consumer
Information on: ReActiv8 Implantable Neurostimulation System
|
| September 4, 2020
New Emergency Use Authorizations
- cobas
SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
- SGTi-flex
COVID-19 IgG (Sugentech, Inc.)
Updated Emergency Use Authorizations
- VIDAS
SARS-CoV-2 IgM (bioMérieux SA) (HCP)
- VIDAS
SARS-CoV-2 IgG (bioMérieux SA) (HCP)
- Bio-Speedy
Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Ltd.) (IFU)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
Use
of International Standard ISO 10993-1, "Biological evaluation
of medical devices - Part 1: Evaluation and testing within a risk
management process" - Guidance for Industry and Food and Drug
Administration Staff
Meeting
Materials for September 8-9, 2020 Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices Advisory Committee
Virtual
Public Meeting - Medical Device User Fee Amendments for Fiscal Years
2023 Through 2027 - October 27, 2020
Federal
Register: Medical Device User Fee Amendments for Fiscal Years 2023
Through 2027
FAQs
on Testing for SARS-CoV-2 (Update)
MedSun
Newsletter, September 2020
|
|
September 3, 2020
New Emergency Use Authorizatons
- Bio-Speedy
Direct RT-qPCR SARS-CoV-2 (Bioeksen R&D Technologies Ltd.)
Updated Emergency Use Authorizatons
- Appendix
B: Authorized Ventilators
- Boston
Heart COVID-19 RT-PCR Test (Boston Heart Diagnostics)
Presentation
and Transcript added to Immediately in Effect Guidance on Coronavirus
(COVID-19) Diagnostic Tests Webinar - August 26, 2020
Conduct
a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator
(SCS) - Letter to Health Care Providers
FAQs
on Testing for SARS-CoV-2 (Updated)
Federal
Register: Ophthalmic Devices Panel of the Medical Devices Advisory
Committee
Federal
Register: Electronic Submission Process for Voluntary Allegations
to the Center for Devices and Radiological Health
|
|
September 2, 2020
New Emergency Use Authorizations
- MobileDetect
Bio BCC19 (MD-Bio BCC19) Test Kit (Detectachem Inc.)
- Kaira
2019-nCoV Detection Kit (OPTOLANE Technologies, Inc.)
- Color
COVID-19 Test Unmonitored Collection Kit (Color Genomics, Inc.)
Updated Emergency Use Authorizations
- U-TOP
COVID-19 Detection Kit (SEASUN BIOMATERIALS) (Revision IFU, HCP,
Patients; Add Letter Granting EUA Revisions)
- Tell
Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Biocan
Diagnostics Inc.) (IFU)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190042
added)
August
2020 PMA Approval List
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
September 1, 2020
New Emergency Use Authorizations
- T2SARS-CoV-2
Panel (T2 Biosystems, Inc.)
- MiraDx
SARS-CoV-2 RT-PCR assay (MiraDx)
- SARS-CoV-2
DETECTR Reagent Kit (Mammoth Biosciences, Inc.)
- BayCare
SARS-CoV-2 RT PCR Assay (BayCare Laboratories, LLC)
- TBG
SARS-CoV-2 IgG / IgM Rapid Test Kit (TBG Biotechnology Corp.)
- COVID-19
ELISA pan-Ig Antibody Test (University of Arizona Genetics Core
for Clinical Services)
Updated Emergency Use Authorizations
- Ventilators
and Ventilator Accessories EUAs
- CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Clinical Research Sequencing Platform (CRSP), LLC at the
- Broad
Institute of MIT and Harvard) (Revision, HCP, Patients, EUA Summary)
- RightSign
COVID-19 IgG/IgM Rapid Test Cassette (Hangzhou Biotest Biotech Co.,
Ltd.) (Revision, IFU)
- AMPIPROBE
SARS-CoV-2 Test System (Enzo Life Sciences, Inc.) (IFU)
- BioCheck
SARS-CoV-2 IgG and IgM Combo Test (BioCheck, Inc.) (IFU)
MQSA
National Statistics
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Consumer
Information on: Kendall™ Multifunction Defibrillation Electrodes
- P190007
|
|
August 31, 2020
New Emergency Use Authorizations
- PCL
SARS-CoV-2 Real-Time RT-PCR Assay (Patients Choice Laboratories,
LLC)
- DxTerity
SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)
Updated Emergency Use Authorizations
- SARS-CoV-2
(N gene detection) Test (Exact Sciences Laboratories) (EUA Summary,
IFU, Revision)
- Color
Genomics SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Genomics, Inc.)
(EUA Summary, HCP, Patients, Revision)
- Novel
Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence
Probing) (Jiangsu CoWin Biotech Co., Ltd.) (IFU)
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases) (Letter, HCP, Patients)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
Webinar
Reminder - CDC/NIOSH's Surgical N95 Respirator Guidance - September
1, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
|
| August 28, 2020
New Emergency Use Authorizations
- Cuur
Diagnostics SARS-CoV-2 Molecular Assay (Cuur Diagnostics)
Consumer
Information on: Guardant360 CDx – P200010
Webinar
Series - CDC/NIOSH's Surgical N95 Respirator Guidance - September
1, 2020
Meeting
Notice: October 22, 2020 Patient Engagement Advisory Committee
Virtual
Town Hall Series - Immediately in Effect Guidance on Coronavirus
(COVID-19) Diagnostic Tests - September 2, 2020
Federal
Register: Principles for Selecting, Developing, Modifying, and Adapting
Patient-Reported Outcome Instruments for Use in Medical Device Evaluation;
Draft Guidance for Industry, Food and Drug Administration Staff,
and Other Stakeholders; Availability
FAQs
on Testing for SARS-CoV-2 (Updated)
Stop
Using Gowns, including Surgical Gowns, from Laws of Motion PPE -
Letter to Health Care Providers
|
|
August 27, 2020
Presentation
and Transcript added to Immediately in Effect Guidance on Coronavirus
(COVID-19) Diagnostic Tests Webinar - August 19, 2020
Presentation
and Transcript added to FDA’s Surgical Masks Umbrella EUA Webinar
- August 18, 2020
Federal
Register: Meetings - Patient Engagement Advisory Committee
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
August 26, 2020
New Emergency Use Authorizations
- Advanta
Dx SARS-CoV-2 RT-PCR Assay (Fluidigm Corporation)
- QDX
SARS-CoV-2 Assay (QDx Pathology Services)
- Tell
Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test (Biocan
Diagnostics Inc.)
- BinaxNOW
COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases) (EUA Summary, Revision)
FAQs
on Testing for SARS-CoV-2 (Updated)
Webinar
Reminder - Regulatory Overview for Developers and Sponsors of Neurological
and Physical Medicine Devices: An Introduction to the De Novo Pathway
- August 27, 2020
|
|
August 25, 2020
Updated Emergency Use Authorizatons
- Respirator
Models Removed from Appendix A (Respirator Models No Longer Authorized)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
August 24, 2020
New Emergency Use Authorizations
- Guardant-19
(Guardant Health, Inc.)
- DxTerity
SARS-CoV-2 RT-PCR Test (DxTerity Diagnostics, Inc.)
- Texas
Department of State Health Services (DSHS) SARS-CoV-2 Assay (Texas
Department of State Health Services, Laboratory Services Section)
Updated Emergency Use Authorizations
- Quest
Diagnostics PF SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease,
Inc.)
- Quest
Diagnostics RC SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease,
Inc.)
- Quest
Diagnostics HA SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease,
Inc.)
- Cue
COVID-19 Test (Cue Health Inc.)
- Biomeme
SARS-CoV-2 Real-Time RT-PCR Test (Biomeme, Inc.)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- Illumina
COVIDSeq Test (Illumina, Inc.) (IFU, Revision Letter)
- Smart
Detect SARS-CoV-2 rRT-PCR Kit (InBios International, Inc.) (IFU,
Revision Letter)
- Alinity
m SARS-CoV-2 assay (Abbott Molecular Inc.) (HCP, Patients, IFU,
Revision Letter)
- Accula
SARS-Cov-2 Test (Mesa Biotech Inc.) (HCP, Patients, IFU, Revision
Letter)
- Ethos
Laboratories SARS-CoV-2 MALDI-TOF Assay (Ethos Laboratories) (IFU)
FAQs
on Testing for SARS-CoV-2 (Updated)
Pooled
Sample Testing and Screening Testing for COVID-19
Class
I Recall: Smiths Medical Recalls Medfusion 3500 and 4000 Syringe
Pumps Due to Risk of Medication Delivery Error
|
| August 21, 2020
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
Protective
Barrier Enclosures Without Negative Pressure Used During the COVID-19
Pandemic May Increase Risk to Patients and Health Care Providers
- Letter to Health Care Providers
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
August 20, 2020
New Emergency Use Authorizations
- Nova2200
(NovaSterilis, Inc.)
Updated Emergency Use Authorizations
- Assurance
SARS-CoV-2 Panel (Assurance Scientific Laboratories)
- Sofia
SARS Antigen FIA (Quidel Corporation)
- SARS-CoV-2
(N gene detection) Test (Exact Sciences Laboratories)
- EURORealTime
SARS-Cov-2 (Euroimmun US, Inc.)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
Meeting
Notice: October 7, 2020 Circulatory System Devices Panel of the
Medical Devices Advisory Committee
Medical
Device Reports for Systemic Symptoms in Women with Breast Implants
Medical
Device Reports of Breast Implant-Associated Anaplastic Large Cell
Lymphoma (Updated)
Video:
7 Key Things You Should Know about Breast Implants
FDA
News Release: FDA Updates Analysis of Medical Device Reports of
Breast Implant Illness and Breast Implant-Associated Lymphoma
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
August 19, 2020
New Emergency Use Authorizations
- LumiraDx
SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
Updated Emergency Use Authorizations
- ePlex
SARS-CoV-2 Test (GenMark Diagnostics, Inc.)
- Appendix
A: Authorized Surgical Masks
- Appendix
B: Authorized Ventilators
Webinar
- Regulatory Overview for Developers and Sponsors of Neurological
and Physical Medicine Devices: An Introduction to the De Novo Pathway
- August 27, 2020
UV
Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus
Ultraviolet
(UV) Radiation (Updated)
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Federal
Register: Medical Devices; Reports of Corrections and Removals
Federal
Register: Circulatory System Devices Panel of the Medical Devices
Advisory Committee
|
|
August 18, 2020
New Emergency Use Authorizations
- COVID-19
Nucleic Acid RT-PCR Test Kit (ZhuHai Sinochips Bioscience Co., Ltd.)
- BioCheck
SARS-CoV-2 IgG and IgM Combo Test (BioCheck, Inc.)
- Diazyme
DZ-Lite SARS-CoV-2 IgM CLIA Kit (Diazyme Laboratories, Inc.)
Public
Workshop - Orthopedic Device-Related Infections - November 13, 2020
Considerations
for Selecting Respirators for Your Health Care Facility
Manufacturing
and Distributing Respirators for Health Care Use in the United States
Under an Existing Emergency Use Authorization (EUA) During the COVID-19
Pandemic
FAQs
on Emergency Use Authorizations (EUAs) for Medical Devices During
the COVID-19 Pandemic (Updated)
Consumer
Information on: The Arctic Front Advance™ and Arctic Front
Advance Pro™ and The Freezor Max™ Cardiac Cryoablation
Catheters - P100010/S098
Archived
Webcast and Presentations added to Public Workshop - Spinal Device
Premarket Review - August 13, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
August 17, 2020
Updated Emergency Use Authorizations
- LetsGetChecked
Coronavirus (COVID-19) Test (PrivaPath Diagnostics, Inc.)
Risk
of Inaccurate Results with Thermo Fisher Scientific TaqPath COVID-19
Combo Kit - Letter to Clinical Laboratory Staff and Health Care
Providers
Catalog
of Regulatory Science Tools to Help Assess New Medical Devices
EUA
Authorized Serology Test Performance (Updated)
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Federal
Register: Petition for an Administrative Stay of Action: Electrical
Stimulation Devices for Self-Injurious or Aggressive Behavior
|
| August 15, 2020
New Emergency Use Authorizations
- SalivaDirect
(Yale School of Public Health, Department of Epidemiology of Microbial
Diseases)
FDA
News Release: Coronavirus (COVID-19) Update: FDA Issues Emergency
Use Authorization to Yale School of Public Health for SalivaDirect,
Which Uses a New Method of Saliva Sample Processing
|
|
August 14, 2020
Updated Emergency Use Authorizations
- Personal
Protective Equipment EUAs
- GenePro
SARS-CoV-2 Test (Gencurix, Inc.)
- Platelia
SARS-CoV-2 Total Ab assay (Bio-Rad Laboratories, Inc.)
- LIAISON
SARS-CoV-2 S1/S2 IgG (DiaSorin Inc.)
- Intersurgical
StarMed CaStar R Hood for NIV (Intersurgical, Inc)
Medical
Device Accessory Classification Request Granting Decisions
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Medical
Device Shortages During the COVID-19 Public Health Emergency
Federal
Register: Physical Medicine Devices: Reclassification of Non-Invasive
Bone Growth Stimulators
|
|
August 13, 2020
New Emergency Use Authorizations
- Pro-AmpRT
SARS-CoV-2 Test (Pro-Lab Diagnostics)
Updated Emergency Use Authorizations
- LYHER
Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal
Gold) (Hangzhou Laihe Biotech Co., Ltd.)
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- TRUPCR
SARS-CoV-2 Kit (3B Blackbio Biotech India Ltd., a subsidiary of
Kilpest India Ltd.)
- UTHSC/UCH
SARS-CoV-2-RT-PCR Assay (UTMG Pathology Laboratory)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
FAQs
on Testing for SARS-CoV-2 (Updated)
Presentation
and Transcript added to August 4, 2020 - Webinar Series - FDA’s
Regulation of Face Masks and Surgical Masks During the COVID-19
Pandemic
Cutaneous
Electrodes for Recording Purposes - Performance Criteria for Safety
and Performance Based Pathway - Guidance for Industry and Food and
Drug Administration Staff
Conventional
Foley Catheters - Performance Criteria for Safety and Performance
Based Pathway - Guidance for Industry and Food and Drug Administration
Staff
Safety
and Performance Based Pathway (Updated)
Webinar
- Safety and Performance Based Pathway Criteria for Certain Device
Types Final Guidances - September 24, 2020
Consumer
Information on: Neuroform Atlas® Stent System – P180031/S001
Webinar
Series - FDA’s Surgical Masks Umbrella EUA - August 18, 2020
Federal
Register: Safety and Performance Based Pathway Device-Specific Guidances
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals:Medical Devices; Humanitarian Use Devices
|
|
August 12, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
New Emergency Authorizations
- Biomeme
SARS-CoV-2 Real-Time RT-PCR Test (Biomeme, Inc.)
- LumiraDx
SARS-CoV-2 RNA STAR (LumiraDx UK Ltd.)
Updated Emergency Use Authorizations
- Ethos
Laboratories SARS-CoV-2 MALDI-TOF Assay (Ethos Laboratories)
- Hymon
SARS-CoV-2 Test Kit (dba SpectronRX)
Virtual
Town Hall Series - Immediately in Effect Guidance on Coronavirus
(COVID-19) Diagnostic Tests - August 19, 2020
|
|
August 11, 2020
New Emergency Use Authorizations
- Solaris
Multiplex SARS-CoV-2 Assay (Solaris Diagnostics)
- Alpha
Genomix TaqPath SARS-CoV-2 Combo Assay (Alpha Genomix Laboratories)
- Prismaflex
HF20 Set (Baxter Healthcare Corporation)
Updated Emergency Use Authorizations
- Smart
Detect SARS-CoV-2 rRT-PCR Kit (InBios International, Inc.)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
FAQs
on Testing for SARS-CoV-2 (Updated)
FDA
In Brief: FDA Posts Additional Postmarket Information for Essure
Problems
Reported with Essure
ESSURE
Medical Device Reporting Variance Spreadsheet - June 2020
Consumer
Information on: WATCHMAN Left Atrial Appendage Closure Device with
Delivery System and WATCHMAN FLX Left Atrial Appendage Closure Device
with Delivery System – P130013/S035
Registration
and Listing of Medical Devices during the COVID-19 Pandemic
Importing
Medical Devices During the COVID-19 Pandemic
|
|
August 10, 2020
Presentation
and Transcript added to August 5, 2020 - Virtual Town Hall Series
- Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic
Tests
New Emergency Use Authorizations
- GWU
SARS-CoV-2 RT-PCR Test (George Washington University Public Health
Laboratory)
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- Appendix
B: Authorized Ventilator Accessories
- Dimension
EXL SARS-CoV-2 Total Antibody Assay (CV2T) (Siemens Healthcare Diagnostics)
- Dimension
Vista SARS-CoV-2 Total Antibody Assay (COV2T) (Siemens Healthcare
Diagnostics)
- PhoenixDx
SARS-CoV-2 Multiplex (Trax Management Services Inc.)
- PhoenixDx
2019-CoV (Trax Management Services Inc.)
- Xpert
Xpress SARS-CoV-2 test (Cepheid)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
| August 8, 2020
New Emergency Use Authorizations
- Appendix
A: Authorized Surgical Masks
|
|
August 7, 2020
Revoked Emergency Use Authorizations
- Autiobio
Diagnostics Anti-SARS-CoV-2 Rapid Test - Letter of Revocation
New Emergency Use Authorizations
- WANTAI
SARS-CoV-2 Ab ELISA (Beijing Wantai Biological Pharmacy Enterprise
Co., Ltd.)
- VIDAS
SARS-CoV-2 IgM (bioMérieux SA)
- VIDAS
SARS-CoV-2 IgG (bioMérieux SA)
- Helix
COVID-19 NGS Test (Helix OpCo LLC (dba Helix))
- ViroKey
SARS-CoV-2 RT-PCR Test (Vela Operations Singapore Pte Ltd)
Updated Emergency Use Authorizations
- Quest
SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.)
- BD
Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson
and Company (BD))
- SCoV-2
Detect IgM ELISA (InBios International, Inc.)
- SCoV-2
Detect IgG ELISA (InBios International, Inc.)
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories - Authorized Ventilators
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN200001,
DEN200015 and DEN200026 added)
|
|
August 6, 2020
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
Presentation
and Transcript added to July 29, 2020 - Virtual Town Hall Series
- Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic
Tests
Umbrella
EUA for Surgical Masks
MedSun
Newsletter, August 2020
|
|
August 5, 2020
New Emergency Use Authorizations
- Genus
SARS-CoV-2 Assay (ISPM Labs, LLC dba Capstone Healthcare)
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- Respirator
Models Removed from Appendix A (Respirator Models No Longer Authorized)
- SARS-CoV-2
(N gene detection) Test (Exact Sciences Laboratories) - EUA Summary
- Appendix
B: Authorized Ventilators
- Appendix
B: Authorized Ventilator Accessories
July
2020 PMA Approval List
Class
I Recall: CME America Updates Recall of BodyGuard Infusion Pump
System Due to Risk of Over-, and Under-infusion
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
Accreditation
Scheme for Conformity Assessment (ASCA) Accreditation Body Training
|
|
August 4, 2020
New Emergency Use Authorizations
- Wren
Laboratories COVID-19 PCR Test (Wren Laboratories LLC)
- Ethos
Laboratories SARS-CoV-2 MALDI-TOF Assay (Ethos Laboratories)
- Cleveland
Clinic SARS-CoV-2 Assay (Cleveland Clinic Robert J. Tomsich Pathology
and Laboratory Medicine Institute)
- Poplar
SARS-CoV-2 TMA Pooling assay (Poplar Healthcare)
Updated Emergency Use Authorizations
- SARS-CoV-2
(N gene detection) Test (Exact Sciences Laboratories)
- Biohit
SARS-CoV-2 IgM/IgG Antibody Test Kit (Biohit Healthcare (Hefei)
Co. Ltd)
Medical
Device User Fee Amendments (Updated)
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
|
August 3, 2020
New Emergency Use Authorizations
- Left
Ventricular Support System (Abiomed, Inc., Impella LV Systems)
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
MQSA
National Statistics
FAQs
on Testing for SARS-CoV-2 (Updated)
FAQs
on Viral Transport Media During COVID-19 (Updated)
|
| July 31, 2020
New Emergency Use Authorizations
- CRL
Rapid Response (Clinical Reference Laboratory, Inc.)
- Atellica
IM SARS-CoV-2 IgG (COV2G) (Siemens Healthcare Diagnostics Inc.)
- ADVIA
Centaur SARS-CoV-2 IgG (COV2G) (Siemens Healthcare Diagnostics Inc.)
- UCSD
RC SARS-CoV-2 Assay (University of California San Diego Health)
- SARS-CoV-2
Test Kit (Real-time PCR) (Xiamen Zeesan Biotech Co., Ltd.)
Updated Emergency Use Authorizations
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
- Linea
COVID-19 Assay Kit (Applied DNA Sciences, Inc.)
- Abbott
RealTime SARS-CoV-2 assay (Abbott Molecular)
- Allplex
2019-nCoV Assay (Seegene, Inc.)
- PerkinElmer
New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
FAQs
on Testing for SARS-CoV-2 (Updated)
FDA
News Release: Coronavirus (COVID-19) Update: FDA Authorizes First
Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2
Infection
|
|
July 30, 2020
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- SARS-CoV-2
Molecular Detection Assay (Mayo Clinic Laboratories)
- OPTI
SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
Presentation
and Transcript added to July 21, 2020 Respirators for Health Care
Personnel Use Webinar
FAQs
on Viral Transport Media During COVID-19 (Update)
Risk
of loss of coordination during water-related activities in Parkinson’s
Patients with Deep Brain Stimulators: FDA Safety Communication
Webinar
Series - FDA's Regulation of Face Masks and Surgical Masks During
the COVID-19 Pandemic - August 4, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
July 29, 2020
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- Quest
SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.)
- BIOTIME
SARS-CoV-2 IgG/IgM Rapid Qualitative Test (Xiamen Biotime Biotechnology
Co., Ltd.)
Meeting
Notice: September 8-9, 2020 Orthopaedic and Rehabilitation Devices
Panel of the Medical Devices Advisory Committee
Template
for Manufacturers of Molecular and Antigen Diagnostic COVID-19 Tests
for Non-Laboratory Use
Accelerate
Sustainable Capability (ASC) Pilot Study
FDA
News Release: Coronavirus (COVID-19) Update: FDA Posts New Template
for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab
Settings, Such as Homes, Offices or Schools
Antibody
(Serology) Testing for COVID-19: Information for Patients and Consumers
Federal
Register: Medical Device User Fee Rates for Fiscal Year 2021
|
|
July 28, 2020
New Emergency Use Authorizations
- SNL-NM
2019 nCoV Real-Time RT-PCR Diagnostic Assay (Sandia National Laboratories)
- Lilly
SARS-CoV-2 Assay (Eli Lilly and Company)
Updated Emergency Use Authorizations
- Elecsys
Anti-SARS-CoV-2 (Roche Diagnostics) (IFU, Amendment)
- Allplex
2019-nCoV Assay (Seegene, Inc.) (IFU, HCP, Patients, Amendment)
- Molecular
Diagnostic Template for Commercial Manufacturers
- Molecular
Diagnostic Template for Laboratories
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
Multiple
Function Device Products: Policy and Considerations - Guidance for
Industry and FDA Staff
Webinar
- Multiple Function Device Products: Policy and Considerations -
September 10, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
Federal
Register: Multiple Function Device Products: Policy and Considerations
Federal
Register: Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee
|
|
July 27, 2020
New Emergency Use Authorizations
- BIOTIME
SARS-CoV-2 IgG/IgM Rapid Qualitative Test (Xiamen Biotime Biotechnology
Co., Ltd.)
- CareStart
COVID-19 IgM/IgG (Access Bio, Inc.)
- Airway
Dome (IkonX, Inc.)
- Michigan
State University Decontamination System
Updated Emergency Use Authorizations
- Color
SARS Cov-2 Diagnostic Assay (Color Genomics, Inc.)
|
| July 24, 2020
New Emergency Use Authorizations
- Helix
COVID-19 Test (Helix OpCo LLC (dba Helix))
- Novel
Coronavirus (SARS-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence
Probing) (Jiangsu CoWin Biotech Co., Ltd.)
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- RightSign
COVID-19 IgG/IgM Rapid Test Cassette (Hangzhou Biotest Biotech Co.,
Ltd.)
- BD
Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson
and Company (BD))
- Aptima
SARS-CoV-2 assay (Hologic, Inc. (BD))
- COVID-19
RT-PCR Test (Laboratory Corporation of America (LabCorp))
FAQs
on Testing for SARS-CoV-2 (Updated)
MedSun
Newsletter, July 2020
FDA
News Release: Coronavirus (COVID-19) Update: FDA Authorizes First
Diagnostic Test for Screening of People Without Known or Suspected
COVID-19 Infection
|
|
July 23, 2020
Updated Emergency Use Authorizations
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
FAQs
on Testing for SARS-CoV-2 (Updated)
Federal
Register: Revocation of Authorization of Emergency Use of an In
Vitro Diagnostic Device for Detection and/or Diagnosis of Zika Virus
|
|
July 22, 2020
Coronavirus
(COVID-19) and Medical Devices (Updated)
New Emergency Use Authorizations
- QuantiVirus
SARS-CoV-2 Multiplex Test Kit (DiaCarta, Inc.)
Updated Emergency Use Authorizations
- TRUPCR
SARS-CoV-2 Kit (3B Blackbio Biotech India Ltd., a subsidiary of
Kilpest India Ltd.)
- NeoPlex
COVID-19 Detection Kit (GeneMatrix, Inc.)
- LIAISON
SARS-CoV-2 S1/S2 IgG (DiaSorin Inc.)
- UTHSC/UCH
SARS-CoV-2-RT-PCR Assay (UTMG Pathology Laboratory)
- Appendix
A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured
in China
- Appendix
B: Authorized Ventilators
FDA
Reminds Owners and Operators About Repair and Maintenance of Tanning
Beds and Booths: FDA Safety Communication
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
July 21, 2020
Updated Emergency Use Authorizations
- Alinity
m SARS-CoV-2 assay (Abbott Molecular Inc.)
- iAMP
COVID-19 Detection Kit (Atila BioSystems, Inc.)
- Platelia
SARS-CoV-2 Total Ab assay (Bio-Rad Laboratories, Inc.)
- xMAP
SARS-CoV-2 Multi-Antigen IgG Assay (Luminex Corporation)
- Assure
COVID-19 IgG/IgM Rapid Test Device (Assure Tech. (Hangzhou Co.,
Ltd))
Federal
Register: Exemptions From Premarket Notification: Class II Devices
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
July 20, 2020
New Emergency Use Authorizations
- OraRisk
COVID-19 RT-PCR (Access Genetics, LLC)
- Rapid
COVID-19 IgM/IgG Combo Test Kit (Megna Health, Inc.)
Updated Emergency Use Authorizations
- TaqPath
COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- Sofia
SARS Antigen FIA (Quidel Corporation)
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
FAQs
on Viral Transport Media During COVID-19
FAQs
on Testing for SARS-CoV-2 (Updated)
Appeal
Options Available to Mammography Facilities Concerning Adverse Accreditation
Decisions, Suspension/Revocation of Certificates, or Patient and
Physician Notification Orders - Draft Guidance for Mammography Facilities
and Food and Drug Administration Staff
Federal
Register: Appeal Options Available to Mammography Facilities Concerning
Adverse Accreditation Decisions, Suspension/Revocation of Certificates,
or Patient and Physician Notification Orders
Enforcement
Policy for Viral Transport Media During the Coronavirus Disease
2019 (COVID-19) Public Health Emergency - Guidance for Commercial
Manufacturers, Clinical Laboratories, and Food and Drug Administration
Staff
|
| July 18, 2020
Updated Emergency Use Authorizations
- Quest
SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
July 17, 2020
New Emergency Use Authorizations
- Boston
Heart COVID-19 RT-PCR Test (Boston Heart Diagnostics)
- xMAP
SARS-CoV-2 Multi-Antigen IgG Assay (Luminex Corporation)
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
Third
Party Performance Report - FY20, Q3
Class
I Recall: Verathon, Inc. Recalls GlideScope Core One TouchSmart
Cable (“OneTouch cable”), Due to partial or complete loss
of image during use
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
July 16, 2020
New Emergency Use Authorizations
- Quest
Diagnostics PF SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease,
Inc.)
- Quest
Diagnostics RC SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease,
Inc.)
- Quest
Diagnostics HA SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease,
Inc.)
Updated Emergency Use Authorizations
- PowerChek
2019-nCoV Real-time PCR Kit (KogeneBiotech Co., Ltd.)
- Assurance
SARS-CoV-2 Panel (Assurance Scientific Laboratories)
- Smart
Detect SARS-CoV-2 rRT-PCR Kit (InBios International, Inc.)
- BD
Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson
and Company (BD))
Presentation
and Transcript added to Virtual Town Hall Series - Immediately in
Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - July
8, 2020
Presentation
and Transcript added to Webinar Series - Respirators for Health
Care Personnel Use during COVID-19 Pandemic - July 7, 2020
EUA
Authorized Serology Test Performance (Updated)
Webinar
Series - Respirators for Health Care Personnel Use During the COVID-19
Pandemic - July 21, 2020
Virtual
Town Hall Series - Immediately in Effect Guidance on Coronavirus
(COVID-19) Diagnostic Tests - July 22, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
July 15, 2020
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
FAQs
on Testing for SARS-CoV-2 (Updated)
Public
Meeting - Using Patient Preference Information in Medical Device
Regulatory Decisions: Benefit-Risk and Beyond - September 29, 2020
|
|
July 14, 2020
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
Providing
Regulatory Submissions for Medical Devices in Electronic Format
- Submissions Under Section 745A(b) of the Federal Food, Drug, and
Cosmetic Act - Guidance for Industry and Food and Drug Administration
Staff
Clinical
Investigations for Prostate Tissue Ablation Devices - Guidance for
Industry and Food and Drug Administration Staff
|
|
July 13, 2020
New Emergency Use Authorizations
- BMC-CReM
COVID-19 Test (Boston Medical Center)
- WANTAI
SARS-CoV-2 Ab Rapid Test (Beijing Wantai Biological Pharmacy Enterprise
Co., Ltd.)
Updated Emergency Use Authorizations
- Influenza
SARS-CoV-2 (Flu SC2) Multiplex Assay (Centers for Disease Control
and Prevention (CDC))
Select
Updates for Guidance for the Non-Clinical and Clinical Investigation
of Devices Used for the Treatment of Benign Prostatic Hyperplasia
(BPH) - Draft Guidance for Industry and Food and Drug Administration
Staff
FDA
Updates Recognized Consensus Standards Database
Federal
Register: Non-Clinical and Clinical Investigation of Devices Used
for the Treatment of Benign Prostatic Hyperplasia
Federal
Register: Revocation of Authorization: Emergency Use of an In Vitro
Diagnostic Device for Detection of Antibodies Against SARS-CoV-2,
the Virus that Causes Coronavirus Disease 2019 (COVID-19)
Federal
Register: Authorization of Emergency Use of Certain Medical Devices
during COVID-19
FAQs
on Testing for SARS-CoV-2 (Updated)
|
| July 10, 2020
New Emergency Use Authorizations
- electroCore,
Inc., gammaCore Sapphire CV
Select
Updates for Peripheral Vascular Atherectomy Devices - Premarket
Notification [510(k)] Submissions - Draft Guidance for Industry
and Food and Drug Administration Staff
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
July 9, 2020
New Emergency Use Authorizations
- CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Clinical Research Sequencing Platform (CRSP), LLC at the Broad
Institute of MIT and Harvard)
- Diazyme
DZ-Lite SARS-CoV-2 IgG CLIA Kit (Diazyme Laboratories, Inc.)
- Real-Q
2019-nCoV Detection Kit (BioSewoom, Inc.)
- SARS-CoV-2
RNA DETECTR Assay (UCSF Health Clinical Laboratories, UCSF Clinical
Labs at China Basin)
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Respirator
Models Removed from Appendix A (Respirator Models No Longer Authorized)
- Appendix
B: Authorized Ventilator Accessories
- Linea
COVID-19 Assay Kit (Applied DNA Sciences, Inc.)
- FTD
SARS-CoV-2 (Fast Track Diagnostics Luxembourg S.á.r.l., a
Siemens Healthineers Company)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
July 8, 2020
New Emergency Use Authorizations
- AMPIPROBE
SARS-CoV-2 Test System (Enzo Life Sciences, Inc.)
- CareStart
COVID-19 MDx RT-PCR (Access Bio, Inc.)
- Gene
By Gene SARS-CoV-2 Detection Test (Gene By Gene)
Updated Emergency Use Authorizations
- COVID-19
Coronavirus Real Time PCR Kit (Jiangsu Bioperfectus Technologies
Co., Ltd.)
-
LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test
Kit (Colloidal Gold) (Hangzhou Laihe Biotech Co., Ltd.)
FAQs
on Testing for SARS-CoV-2 (Updated)
June
2020 PMA Approval List
|
|
July 7, 2020
New Emergency Use Authorizations
- Laboratorio
Clinico Toledo SARS-CoV-2 Assay
- Assure
COVID-19 IgG/IgM Rapid Test Device (Assure Tech. - Hangzhou Co.,
Ltd)
Updated Emergency Use Authorizations
- LetsGetChecked
Coronavirus (COVID-19) Test (PrivaPath Diagnostics, Inc.) - Letter
Granting EUA Amendment(s) (July 6, 2020)
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Respirator
Models Removed from Appendix A (Respirator Models No Longer Authorized)
- CLEWICU
System - Letter Granting EUA Amendment(s) (June 30, 2020)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
July 6, 2020
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
Webinar
Series - Respirators for Health Care Personnel Use during COVID-19
Pandemic - July 7, 2020
|
| July 2, 2020
New Emergency Use Authorizations
- CentoFast-SARS-CoV-2
RT-PCR Assay (CENTOGENE US, LLC)
- SCoV-2
Detect IgM ELISA (InBios International, Inc.)
- Influenza
SARS-CoV-2 (Flu SC2) Multiplex Assay (Centers for Disease Control
and Prevention (CDC))
Updated Emergency Use Authorizations
- COVID-19
RT-PCR Test (LabCorp)
Webinar
Series - Respirators for Health Care Personnel Use during COVID-19
Pandemic - July 7, 2020
MQSA
Inspection Information Related to COVID-19 (Updated)
Class
I Recall: Arrow International Inc. Recalls Arrow AutoCAT®2 and
AC3 Optimus® IABP Series Due to Possible Breakdown of Motor
Connector Wires
FAQs
on Testing for SARS-CoV-2 (Updated)
FDA
News Release - Coronavirus (COVID-19) Update: FDA Authorizes Additional
COVID-19 Combination Diagnostic Test Ahead of Flu Season
|
|
July 1, 2020
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
Consumer
Information on: FoundationOne®CDx - P170019/S016
Consumer
Information on: JUVÉDERM® VOLUMA™ XC - P110033/S047
MQSA
National Statistics
FAQs
on Testing for SARS-CoV-2 (Updated)
|
| June 30, 2020
New Emergency Use Authorizations
- Acupath
COVID-19 Real-Time (RT-PCR) Assay (Acupath Laboratories, Inc.)
- Psoma
COVID-19 RT Test (Psomagen, Inc.)
- COVID-19
RT-PCR Peptide Nucleic Acid (PNA) kit (TNS Co., Ltd - Bio TNS)
- Kroger
Health COVID-19 Test Home Collection Kit (The Kroger Co.)
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Gravity
Diagnostics COVID-19 Assay (Gravity Diagnostics, LLC) (EUA Summary,
Amendment)
Unique
Device Identification: Policy Regarding Compliance Dates for Class
I and Unclassified Devices and Certain Devices Requiring Direct
Marking - Immediately in Effect Guidance for Industry and Food and
Drug Administration Staff
Mammography
Facility Adverse Event and Action Report - June 29, 2020: Wagoner
Community Hospital
Consumer
Information on: cobas® EZH2 Mutation Test - P200014
Development
of 21st Century Cures Act Section 3060 Required Report: Request
for Input
FAQs
on Testing for SARS-CoV-2 (Updated)
Federal
Register: Unique Device Identification: Policy Regarding Compliance
Dates for Class I and Unclassified Devices and Certain Devices Requiring
Direct Marking
|
|
June 29, 2020
New Emergency Use Authorization
- LifeHope
2019-nCoV Real-Time RT-PCR Diagnostic Panel (LifeHope Labs)
- Access
SARS-CoV-2 IgG (Beckman Coulter, Inc.)
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Appendix
B: Authorized Ventilators
- IntelliPlex
SARS-CoV-2 Detection Kit (PlexBio Co., Ltd.) (IFU, Patients)
Consumer
Information on: Inspire® Upper Airway Stimulation - P130008/S039
EUA
Authorized Serology Test Performance (Updated)
Presentation
and Transcript added to June 24 Virtual Town Hall Series - Immediately
in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
FAQs
on Testing for SARS-CoV-2 (Updated)
|
| June 26, 2020
New Emergency Use Authorizations
- FastPlex
Triplex SARS-CoV-2 detection kit (RT-Digital PCR) (PreciGenome LLC)
- IntelliPlex
SARS-CoV-2 Detection Kit (PlexBio Co., Ltd)
- Inform
Diagnostics SARS-CoV-2 RT-PCR Assay (Inform Diagnostics, Inc.)
Updated
Templates for Serology EUA Requests
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
June 25, 2020
New Emergency Use Authorizations
- MD
Anderson High-throughput SARS-CoV-2 RT-PCR Assay
- DSL
COVID-19 Assay
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilators
- Phosphorus
COVID-19 RT-qPCR Test
- Babson
Diagnostics aC19G1
Presentations
and Transcripts added to June 10 and June 17 Virtual Town Hall Series
- Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic
Tests
Presentation
and Transcript added to June 9 Webinar Series - Respirators for
Health Care Personnel Use during COVID-19 Pandemic
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
June 24, 2020
New Emergency Use Authorizations
- GenePro
SARS-CoV-2 Test (Gencurix, Inc.)
- HealthQuest
Esoterics TaqPath SARS-CoV-2 Assay (HealthQuest Esoterics)
- FRL
SARS CoV-2 Test (University of Alabama at Birmingham Fungal Reference
Lab)
- Babson
Diagnostics aC19G1 (Babson Diagnostics, Inc.)
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilator Accessories
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Respirator
Models Removed from Appendix A (Respirator Models No Longer Authorized)
FAQs
on Testing for SARS-CoV-2 (Updated)
Medical
Device Development Tools (MDDT) - Added Insulin Dosing Systems:
Perceptions, Ideas, Reflections, and Expectations (INSPIRE) Questionnaires
|
|
June 23, 2020
Reissued Emergency Use Authorizations
- COVID-19
Airway Management Isolation Chamber (CAMIC) (U.S. Army Medical Research
and Development Command (USAMRDC))
New Emergency Use Authorizations
- Hangzhou
Laihe Biotech Co., Ltd. LYHER Novel Coronavirus (2019-nCoV) IgM/IgG
Antibody Combo Test Kit (Colloidal Gold)
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Respirator
Models Removed from Appendix A (Respirator Models No Longer Authorized)
- Abbott
Laboratories Inc. SARS-CoV-2 IgG assay - Letter Granting EUA Amendment(s)
(June 22, 2020)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
June 22, 2020
Updated Emergency Use Authorizations
- Appendix
B: Authorized Ventilators
- Exhibit
1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece
Respirators (FFR)
Effects
of the COVID-19 Public Health Emergency on Formal Meetings and User
Fee Applications for Medical Devices - Questions and Answers - Guidance
for Industry and Food and Drug Administration Staff
FAQs
on Testing for SARS-CoV-2 (Updated)
|
| June 19, 2020
New Emergency Use Authorizations
- COVID-19
Coronavirus Real Time PCR Kit (Jiangsu Bioperfectus Technologies
Co., Ltd.)
- TRUPCR
SARS-CoV-2 Kit (3B Blackbio Biotech India Ltd., a subsidiary of
Kilpest India Ltd.)
- OSUWMC
COVID-19 RT-PCR test (The Ohio State University Wexner Medical Center)
- Omni
COVID-19 Assay by RT-PCR (Omnipathology Solutions Medical Corporation)
- Biohit
SARS-CoV-2 IgM/IgG Antibody Test Kit (Biohit Healthcare (Hefei)
Co. Ltd.)
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Respirator
Models Removed from Appendix A (Respirator Models No Longer Authorized)
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools)
Non-contact
Temperature Assessment Devices During the COVID-19 Pandemic
Certain
COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to
Clinical Laboratory Staff and Health Care Providers
FAQs
on Testing for SARS-CoV-2 (Updated)
Notifying
CDRH of a Permanent Discontinuance or Interruption in Manufacturing
of a Device Under Section 506J of the FD&C Act During the COVID-19
Public Health Emergency - Guidance for Industry and Food and Drug
Administration Staff (Revised)
Medical
Device Types to Help Determine Section 506J Notification Obligations
Medical
Device Supply Chain Notifications During the COVID-19 Public Health
Emergency
Contact
the FDA About a Medical Device Supply Chain Issue
|
|
June 17, 2020
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Respirator
Models Removed from Appendix A (Respirator Models No Longer Authorized)
- Appendix
B - Authorized Ventilator Tubing Connectors
- Appendix
B - Authorized Ventilators
FAQs
on Testing for SARS-CoV-2 (Updated)
Virtual
Public Meeting - Patient-Reported Outcomes (PROs) and Medical Device
Investigations: From Conception to Implementation - September 30,
2020
Press
Release: Coronavirus (COVID-19) Update: FDA Issues Warning Letters
to Companies Inappropriately Marketing Antibody Tests, Potentially
Placing Public Health at Risk
Webinar
Series - Respirators for Health Care Personnel Use during COVID-19
Pandemic - June 23, 2020
EUA
Authorized Serology Test Performance (Updated)
|
|
June 16, 2020
New Emergency Use Authorizations
- BioCode
SARS-CoV-2 Assay (Applied BioCode, Inc.)
- SARS-CoV-2
RBD IgG test (Emory Medical Laboratories)
- KPMAS
COVID-19 Test (Kaiser Permanente Mid-Atlantic States)
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Fulgent
COVID-19 by RT-PCR Test (Fulgent Therapeutics, LLC)
- CDC
2019-nCoV Real-Time RT-PCR Diagnostic Panel (Centers for Disease
Control and Prevention's (CDC))
- Warrior
Diagnostics SARS-CoV-2 Assay (Warrior Diagnostics, Inc.)
Revoked Emergency Use Authorization
- DPP
COVID-19 IgM/IgG System (Chembio Diagnostic System, Inc.)
Class
I Recall: Endologix Inc. Recalls Ovation iX Abdominal Stent Graft
Systems Due to Risks of Polymer Leaks During Implantation
FAQs
on Testing for SARS-CoV-2 (Updated)
FDA
News Release: Coronavirus (COVID-19) Update: Facilitating Diagnostic
Test Availability for Asymptomatic Testing and Sample Pooling
FDA
News Release: Coronavirus (COVID-19) Update: FDA Revokes Emergency
Use Authorization for Chembio Antibody Test
|
|
June 15, 2020
New
Emergency Use Authorizations
- Technical Safety Services VHP Decontamination System
- Negative-pressure Respiratory System with Advanced Ventilation
Return (NRSAVR-100)
Updated
Emergency Use Authorizations
- Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators Manufactured in China
- Respirator Models No Longer Authorized
Public
Workshop - Spinal Device Premarket Review - August 13, 2020
Adverse
Event Reporting for Medical Devices Under Emergency Use Authorization
(EUA) or Discussed in COVID-19-Related Guidance Documents
FAQs
on Testing for SARS-CoV-2 (Updated)
FDA
News Release: FDA Permits Marketing of First Game-Based Digital
Therapeutic to Improve Attention Function in Children with ADHD
|
| June 12, 2020
New
Emergency Use Authorizations
- Diagnovital SARS-CoV-2 Real-Time PCR Kit (RTA Laboratories Biological
Products Pharmaceutical and Machinery Industry)
- Cormeum SARS-CoV-2 Assay (Cormeum Laboratory Services)
Updated
Emergency Use Authorizations
- qSARS-CoV-2 IgG/IgM Rapid Test (Cellex Inc.)
- CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (Centers for Disease
Control and Prevention's (CDC))
- BD SARS-CoV-2Reagents for BD MAX System (Becton, Dickinson &
Company)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
June 11, 2020
New
Emergency Use Authorizations
- SCoV-2 Detect IgG ELISA (InBios International, Inc.)
- DTPM COVID-19 RT-PCR Test (Tide Laboratories, LLC)
- ExProbe SARS-CoV-2 Testing Kit (TBG Biotechnology Corp.)
- Cue COVID-19 Test (Cue Health Inc.)
Updated
Emergency Use Authorizations
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
- Molecular
Laboratory Developed Test (LDT) COVID-19 Authorized Tests - Fact
Sheet for Patients
- Curative-Korva SARS-Cov-2 Assay (KorvaLabs Inc.)
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
Presentation
and Transcript added to: Virtual Town Hall Series - Immediately
in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests -
June 3, 2020
Federal
Register: Medical Device User Fee Cover Sheet and Device Facility
User Fee Cover Sheet
|
|
June 10, 2020
New
Emergency Use Authorizations
- Illumina COVIDSeq Test (Illumina, Inc.)
- Warrior Diagnostics SARS-CoV-2 Assay (Warrior Diagnostics, Inc.)
- HDPCR SARS-CoV-2 Assay (ChromaCode Inc.)
Updated
Emergency Use Authorizations
- Respirator Models No Longer Authorized
- Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators Manufactured in China
- Sofia SARS Antigen FIA (Quidel Corporation)
FAQs
on Testing for SARS-CoV-2 (Updated)
Hospital
Beds, Stretchers, and Mattresses During the COVID-19 Public Health
Emergency
|
|
June 9, 2020
New
Emergency Use Authorizations
- Siemens Healthcare Diagnostics Inc., Dimension Vista SARS-CoV-2
Total antibody assay (COV2T)
- Siemens Healthcare Diagnostics Inc., Dimension EXL SARS-CoV-2
Total antibody assay (CV2T)
- Euroimmun US Inc., EURORealTime SARS-CoV-2
Updated
Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Respirator
Models No Longer Authorized - Removed from Appendix A
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
FAQs
on Testing for SARS-CoV-2 (Updated)
EUA
Authorized Serology Test Performance (Updated)
Consumer
Information on: FoundationOne CDx - P170019/S015
Consumer
Information on: PD-L1 IHC 28-8 pharmDx - P150025/S013
|
|
June 8, 2020
New
Emergency Use Authorizations
- Genetron SARS-CoV-2 RNA Test
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
June 7, 2020
Certain
Filtering Facepiece Respirators from China May Not Provide Adequate
Respiratory Protection - Letter to Health Care Providers (Updated)
N95
Respirators, Surgical Masks, and Face Masks (Updated)
FAQs
on the EUAs for Non-NIOSH Approved Respirators During the COVID-19
Pandemic (Updated)
FAQs
on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic
(Updated)
FDA
News Release: Coronavirus (COVID-19) Update: FDA Reissues Emergency
Use Authorizations Revising Which Types of Respirators Can Be Decontaminated
for Reuse
|
| June 6, 2020
Updated
Emergency Use Authorizations
- Advanced Sterilization Products (ASP) STERRAD Sterilization System
- Battelle Decontamination System
- Duke Decontamination System
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Sterilucent, Inc. Sterilization System
- STERIS Sterilization Systems for Decontamination of N95 Respirators
- Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle
- Stryker Sustainability Solutions VHP Decontamination System
|
|
June 5, 2020
New
Emergency Use Authorizations
- Phosphorus Diagnostics LLC Phosphorus COVID-19 RT-qPCR Test
- Hangzhou Biotest Biotech Co., Ltd. RightSign COVID-19 IgG/IgM
Rapid Test Cassette
Updated
Emergency Use Authorizations
- Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit (IFU, Amendment)
- InBios International, Inc Smart Detect SARS-CoV-2 rRT-PCR Kit
(IFU)
- Abbott RealTime SARS-CoV-2 assay (Patients)
- Abbott Laboratories Inc. SARS-CoV-2 IgG assay (Recipients)
- Abbott Molecular Inc. Alinity m SARS-CoV-2 assay (Patients)
- Simplexa COVID-19 Direct assay (IFU, HCP, Patients, Amendment)
- ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection
Kit (IFU, HCP, Patients, Amendment)
- Roche Diagnostics Elecsys Anti-SARS-CoV-2 (IFU, Amendment)
FAQs
on Testing for SARS-CoV-2 (Updated)
Enforcement
Policy for Non-Invasive Remote Monitoring Devices Used to Support
Patient Monitoring During the Coronavirus Disease 2019 (COVID-19)
Public Health Emergency (Revised) - Guidance for Industry and Food
and Drug Administration Staff
|
|
June 4, 2020
Testing
Supply Substitution Strategies (PPT-1.5MB)
- A new web resource for labs performing COVID-19 tests that are
authorized. Download the file, open it, and click Slide Show >
From Beginning.
New
Emergency Use Authorization
- Roche Diagnostics
- Vibrant America Clinical Labs Vibrant COVID-19 Ab Assay
Updated
Emergency Use Authorization
- InBios International, Inc.
- Nebraska Medicine Clinical Laboratory NEcov19 RT-PCR Assay
- Yale New Haven Hospital, Clinical Virology Laboratory SARS CoV-2
Assay
- Altru Diagnostics, Inc. Altru Dx SARS-CoV-2 RT-PCR assay
- SD Biosensor, Inc. STANDARD M nCoV Real-Time Detection Kit
New
Historical Information Emergency Use Authorizations
- DPP Zika IgM Assay System (Chembio Diagnostic System, Inc)
Inspections
of CDER-led or CDRH-led Combination Products (PDF - 837KB)
Transport
Media Safety Risk - Use Compatible Transport Media with SARS-CoV-2
Tests that Use Bleach - Letter to Clinical Laboratory Staff and
Health Care Providers
FAQs
on Testing for SARS-CoV-2 (Updated)
Webinar
Series - Respirators for Health Care Personnel Use during COVID-19
Pandemic - June 9, 2020
EUA
Authorized Serology Test Performance (Updated)
|
|
June 3, 2020
New
Emergency Use Authorizations
- Aspirus Laboratory
- CSI Laboratory
- Gravity Diagnostics, LLC.
Updated
Emergency Use Authorization
- Fosun Pharma USA Inc.
- Abbott Molecular Inc.
- Maccura Biotechnology (USA) LLC
- UTMG Pathology Laboratory
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
Presentation
and Transcript added to: Virtual Town Hall Series - Immediately
in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests -
May 27, 2020
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190040
added)
|
|
June 2, 2020
Updated
Emergency Use Authorization
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Respirator
Models No Longer Authorized - Removed from Appendix A
- Appendix
B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator
Accessories
|
|
June 1, 2020
New
Emergency Use Authorizations
- Abiomed, Inc., Impella RP System
Updated
Emergency Use Authorization
- Appendix B: Ventilator EUA Appendix B Listing
- Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19
- Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents
for BD MAX System
- OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT PCR Test
- Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators Manufactured in China
FAQs
on Testing for SARS-CoV-2 (Updated)
Class
I Recall: Medtronic recalls StealthStation auto-registration feature
due to inaccuracies during deep brain stimulation (DBS) procedures
MQSA
National Statistics
|
| May 30, 2020
New
Emergency Use Authorizations
- Healgen Scientific LLC Diagnostic COVID-19 IgG/IgM Rapid Test
Cassette (Whole Blood/Serum/Plasma)
- Siemens Healthcare Diagnostics Inc. Atellica IM SARS-CoV-2 Total
(COV2T)
- Siemens Healthcare Diagnostics Inc. ADVIA Centaur SARS-CoV-2 Total
(COV2T)
Updated
Emergency Use Authorization
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors,
and Ventilator Accessories
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
May 29, 2020
Home
Specimen Collection Molecular Diagnostic Template
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190037
added)
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
May 28, 2020
New
Emergency Use Authorization
- PrivaPath Diagnostics, Inc. LetsGetChecked Coronavirus (COVID-19)
Test
Updated
Emergency Use Authorization
- Quest Diagnostics Infectious Disease, Inc. Quest SARS-CoV-2 rRT-PCR
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Respirator
Models No Longer Authorized - Removed from Appendix A
eMDR
System Enhancements
Class
I Recall: Medtronic Recalls HeartWare HVAD Pump Outflow Graft and
Outflow Graft Strain Relief Due to Risk of Breaks and Tears During
Set Up
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
May 27, 2020
New
Emergency Use Authorizations
- CLEWICU System - Predictive Screening (CLEW Medical Ltd.)
- VHP Decontamination System (Stryker Sustainability Solutions )
Updated Emergency Use Authorizations
- Appendix
A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
- Respirator
Models No Longer Authorized - Removed from Appendix A
Use
the Correct Cycle and Compatible N95 Respirators When Decontaminating
Respirators with STERRAD Sterilization Systems - Letter to Health
Care Providers
Presentation
and Transcript added to: Virtual Town Hall Series - Immediately
in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests -
May 20, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
May 26, 2020
New
Emergency Use Authorization
- Hymon SARS-CoV-2 Test Kit (dba SpectronRx)
Updated
Emergency Use Authorizations
- Anti-SARS-CoV-2 Rapid Test (Autobio Diagnostics Co. Ltd.)
- RealStar SARS-CoV02 RT-PCR Kits U.S. (altona Diagnostics GmbH)
- RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics)
- RealStar Ebolavirus RT-PCR Kit 1.0 (altona Diagnostics GmbH)
- RealStar MERS-CoV RT-PCR Kit
- Non-NIOSH-Approved
Disposable Filtering Facepiece Respirators Manufactured in China
- Appendix A
- Respirator
Models No Longer Authorized - Removed from Appendix A
FAQs
on Testing for SARS-CoV-2 (Updated)
Enforcement
Policy for Face Masks and Respirators During the Coronavirus Disease
(COVID-19) Public Health Emergency (Revised) - Guidance for Industry
and Food and Drug Administration Staff
Recommendations
for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction
Systems for Face Masks and Respirators During the Coronavirus Disease
2019 (COVID-19) Public Health Emergency - Guidance for Industry
and Food and Drug Administration Staff
|
| May 22, 2020
New
Emergency Use Authorization
- BioCore Co. Ltd.
- SolGent Co. Ltd.
- Seasun Biomaterials, Inc.
- P23 Labs, LLC.
- Gowns and Other Apparel
- Exact Sciences SARS-CoV-2 (N gene detection) Test
- Express Gene 2019-nCoV RT-PCR Diagnostic Panel
- Avera Institute for Human Genetics SARS-CoV-2 Assay
Updated
Emergency Use Authorization
- P23 Labs TaqPath SARS-CoV-2 Assay - IFU Home Collect
Presentation
and Transcript added to: Virtual Town Hall - 3D Printed Swabs
FAQs
on Testing for SARS-CoV-2 (Updated)
Medical
Gloves for COVID-19
|
|
May 21, 2020
New
Emergency Use Authorization
- Color Genomics, Inc.
- Prismaflex ST Set, Baxter Healthcare Corporation
- STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers
Updated
Emergency Use Authorization
- Ortho-Clinical Diagnostic, Inc
- Fosun Pharma USA, Inc.
- Assurance Scientific Laboratories
- Appendix B - Ventilators
2nd
Quarter FY 2020 MDUFA IV Performance Report
FAQs
on Testing for SARS-CoV-2 (Updated)
Supplements
for Approved Premarket Approval (PMA) or Humanitarian Device Exemption
(HDE) Submissions During the Coronavirus Disease 2019 (COVID-19)
Public Health Emergency - Guidance for Industry and Food and Drug
Administration Staff
Consumer
Information on: Philips HeartStart FR3 Defibrillator, Primary Battery,
Rechargeable Battery, Charger for the Rechargeable Battery, SmartPads
III, DP pads, and Pediatric Key - P160028 (Corrected)
Consumer
Information on: HeartStart FRx Defibrillator (861304), Primary Battery
(Model M5070A), Aviation FRx Battery (989803139301), SMART Pads
II (Model 989803139261), and Infant/Child Key (Model 989803139311)
– P180028
|
|
May 20, 2020
Updated
Emergency Use Authorization
- Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators Manufactured in China
Presentation
and Transcript added to: Virtual Town Hall Series - Immediately
in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests -
May 13, 2020
Presentation
and Transcript added to: Webinar - Notifying CDRH of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the FD&C Act During the COVID-19 Public Health
Emergency
|
|
May 19, 2020
New
Emergency Use Authorizations
- Quidel Corporation
Updated
Emergency Use Authorization
- Zymo Research Corporation
Consumer
Information on: FoundationOne CDx - P170019/S011
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
May 18, 2020
Updated
Emergency Use Authorizations
- Abbott Laboratories Inc. SARS-CoV-2 IgG assay - IFU
- Autobio Diagnostics Co. Ltd. Anti-SARS-CoV-2 Rapid Test - IFU,
HCP, Recipients
- Cellex Inc. qSARS-CoV-2 IgG/IgM Rapid Test - IFU, HCP, P
- Roche Diagnostics Elecsys Anti-SARS-CoV-2 - IFU
FAQs
on Testing for SARS-CoV-2 (Updated
|
May 16, 2020
New
Emergency Use Authorizations
- Everlywell COVID-19 Test Home Collection Kit (Everlywell, Inc.)
- Fulgent COVID-19 by RT-PCR Test (Fulgent Therapeutics, LLC)
- Assurance SARS-CoV-2 Panel (Assurance Scientific Laboratories) |
|
May 15, 2020
New
Emergency Use Authorizations
- Aptima SARS-CoV-2 assay (Hologic, Inc.)
- NeoPlex COVID-19 Detection Kit (GeneMatrix, Inc.)
- VSMS Patch (G Medical Innovations, Ltd.)
Updated
Emergency Use Authorizations
- SARS-CoV-2 IgG assay (Abbott Laboratories Inc.)
Contacts
for Medical Devices During the COVID-19 Pandemic
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
May 14, 2020
New
Emergency Use Authorizations
- Applied DNA Sciences, Inc.
- One Health Laboratories, LLC
- Cedars-Sinai Medical Center, Department of Pathology and Laboratory
Medicine
- Infusion Pumps and Infusion Pump Accessories
Updated
Emergency Use Authorizations
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors,
and Ventilator Accessories
- Roche Molecular Systems, Inc (RMS)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190031
added and DEN180065 updated)
FAQs
on Testing for SARS-CoV-2 (Updated)
FDA
News Release: FDA issues warning letters to two breast implant manufacturers
as part of ongoing efforts to protect patients
Federal
Register: Policy for Coronavirus Disease-2019 Tests During the Public
Health Emergency; Immediately in Effect Guidance for Clinical Laboratories,
Commercial Manufacturers, and Food and Drug Administration Staff
|
|
May 13, 2020
New
Emergency Use Authorizations
- Abbott Molecular Inc.
- Columbia University Laboratory of Personalized Genomic Medicine
Updated
Emergency Use Authorizations
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors,
and Ventilator Accessories
- Molecular
Diagnostic Template for Manufacturers
- Molecular
Diagnostic Template for Laboratories
Presentation
and Transcript added to: Virtual Town Hall Series - Immediately
in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests -
May 6, 2020
Virtual
Town Hall - 3D Printed Swabs - May 15, 2020
FAQs
on Testing for SARS-CoV-2 (Updated)
Thermal
Imaging Systems (Infrared Thermographic Systems / Thermal Imaging
Cameras)
Consumer
Information on: TREO® Abdominal Stent-Graft System - P190015
EUA
Authorized Serology Test Performance (Updated)
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Adverse Event Program for Medical Devices (Medical
Product Safety Network)
|
|
May 12, 2020
New
Emergency Use Authorizations
- 1drop Inc.- COVID-19 qPCR Multi Kit
- Ascom(US) Inc. teleCare
- Eko Devices, Inc.
- Pre-Emergency Use Authorization (EUA)/EUA Interactive Review Template
For Non-IVD Products
Updated
Emergency Use Authorizations
- Luminex Corporation
- Zymo Research
- Trax Management Services, Inc.
Class
I Recall: Applied Medical Recalls Python Embolectomy, BARD Embolectomy,
and OTW Latis Cleaning Catheters Due to Risk of Separation During
Use
EUA
Authorized Serology Test Performance (Updated)
|
|
May 11, 2020
New Emergency
Use Authorizations
- Respirator
Models No Longer Authorized for COVID19
Updated
Emergency Use Authorizations
- Molecular
Diagnostic Template for Manufacturers
- Molecular
Diagnostic Template for Laboratories
- Antigen
Template for Manufacturers
- SARS-CoV-2 IgG assay (Abbott Laboratories Inc.)
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent
Pack (Ortho Clinical Diagnostics, Inc.)
- Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's
Hospital
- Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics
- Rutgers University
FAQs
on Testing for SARS-CoV-2 (Updated)
Policy
for Coronavirus Disease-2019 Tests During the Public Health Emergency
(Revised) - Immediately in Effect Guidance for Clinical Laboratories,
Commercial Manufacturers, and Food and Drug Administration Staff
Face
Masks and Surgical Masks for COVID-19: Manufacturing, Purchasing,
Importing, and Donating Masks During the Public Health Emergency
|
|
May 9, 2020
New
Emergency Use Authorizations
- Gnomegen COVID-19-RT-qPCR Detection Kit
- Biocollections Worldwide SARS-Co-V-2 Assay
Updated
Emergency Use Authorizations
- Ventilators - Appendix B
- qSARS-CoV-2 IgG/IgM Rapid Test - IFU
FAQs
on Testing for SARS-CoV-2 (Updated)
|
|
May 8, 2020
New
Emergency Use Authorizations
- Rutgers Clinical Laboratory at RUCDR Infinite Biologics - Rutgers
University
- Zymo Research Corporation
- Patient Isolation Transport Unit (PITU) Device
- Sofia 2 SARS Antigen FIA (Quidel Corporation)
Updated
Emergency Use Authorizations
- Ventilators - Appendix B
FAQs
on Testing for SARS-CoV-2 (Updated)
Consumer
Information on: Tack Endovascular System® (4F, 1.5-4.5mm) -
P190027
|
|
May 7, 2020
New
Emergency Use Authorizations
- OPTI Medical Systems, Inc.
- Sherlock BioSciences, Inc.
- BioMerieux SA
- Duke Decontamination System
Updated
Emergency Use Authorizations
- BioFire Respiratory Panel 2.1
- AIT Laboratories - Appendix A
- Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
Certain
Filtering Facepiece Respirators from China May Not Provide Adequate
Respiratory Protection - Letter to Health Care Providers
FAQs
on Shortages of Surgical Masks and Gowns During the COVID-19 Pandemic
(Updated)
FAQs
on the EUAs for Non-NIOSH Approved Respirators During the COVID-19
Pandemic (Updated)
Risk
of Misinterpreting Hydrogen Peroxide Indicator Colors for Vapor
Sterilization - Letter to Health Care Providers
FAQs
on Testing for SARS-CoV-2 (Updated)
Presentation
and Transcript added to: Webinar - 510(k) Third Party Review Program:
Final Guidance - April 16, 2020
Presentation
and Transcript added to: Virtual Town Hall Series - Immediately
in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests -
April 29, 2020
|
|
May 6, 2020
Notifying
CDRH of a Permanent Discontinuance or Interruption in Manufacturing
of a Device Under Section 506J of the FD&C Act During the COVID-19
Public Health Emergency - Guidance for Industry and Food and Drug
Administration Staff
Webinar
- Notifying CDRH of a Permanent Discontinuance or Interruption in
Manufacturing of a Device Under Section 506J of the FD&C Act
During the COVID-19 Public Health Emergency - May 11, 2020
EUA
Authorized Serology Test Performance (Updated EUROIMMUN SARS-COV-2
ELISA (IgG))
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
|
|
May 5, 2020
New
Emergency Use Authorizations:
- Sansure Biotech Inc.
- Appendix A: UTMG Pathology Laboratory Letter of Authorization
and EUA Summary
- Fast Track Diagnostics SARS-CoV-2
- PhysiolGuard, ECG-QT Analysis System
Updated
Emergency Use Authorizations:
- Bicercna-SARS - EUA Summary
- Roche Diagnostics Elecsys Anti-SARS-CoV-2 - Fact Sheet for Healthcare
Providers
- Cepheid Xpert Xpress SARS-CoV-2 test - IFU for Labs and Point-of-Care
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Consumer
Information on: The therascreen® BRAF V600E RGQ PCR Kit - P190026
Consumer
Information on: The prodisc L Total Disc Replacement – P050010/S020
|
|
May 4, 2020
New
Emergency Use Authorizations:
- Roche Diagnostics Elecsys Anti-SARS-CoV-2
- EUROIMMUN US Inc. Anti-SARS-CoV-2 ELISA (IgG)
Updated
Emergency Use Authorizations:
- VitalConnect, Inc., VitalPatch
FDA
Fact sheet - Antibody Test Oversight and Use for Covid-19
Policy
for Coronavirus Disease-2019 Tests During the Public Health Emergency
(Revised) - Immediately in Effect Guidance for Clinical Laboratories,
Commercial Manufacturers, and Food and Drug Administration Staff
EUA
Authorized Serology Test Performance
April
2020 PMA Approval List
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN180055,
DEN180065 and DEN190026 added)
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
|
May 3, 2020
Updated
Emergency Use Authorizations:
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors,
and Ventilator Accessories |
|
May 2, 2020
New
Emergency Use Authorizations:
- BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (RP2.1)
- Bio-Rad Laboratories, Inc Bio-Rad SARS-CoV-2 ddPCR Test
- Protective Barrier Enclosures
- Liberate Medical, LLC VentFree Respiratory Muscle Stimulator Device
Updated
Emergency Use Authorizations:
- Appendix B-Ventilators
- DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG IFU
- Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's
Hospital Childrens-Altona-SARS-CoV-2 Assay EUA Summary
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
|
|
May 1, 2020
New
Emergency Use Authorizations:
- multiFiltrate PRO System and multiBic/multiPlus Solutions (Fresenius
Medical Care)
- New York SARS-CoV Microsphere Immunoassay for Antibody Detection
(Wadsworth Center, New York State Department of Health)
- Altru Dx SARS-CoV-2 RT-PCR assay (Altru Diagnostics, Inc.)
Updated
Emergency Use Authorizations:
- Appendix B-Ventilators
- BioFire COVID-19 Test (BioFire Defense, LLC)
- Accula SARS-Cov-2 Test (Mesa Biotech Inc.)
Classification
of Posterior Cervical Screw Systems: Small Entity Compliance Guide
- Guidance for Industry and Food and Drug Administration Staff
Federal
Register: Classification of Posterior Cervical Screw Systems: Small
Entity Compliance Guide
MQSA
National Statistics
Medical
Gloves for COVID-19: Manufacturing, Purchasing, Importing and Donating
Gloves During the Public Health Emergency
|
|
April 30, 2020
New
Emergency Use Authorizations:
- LabGun COVID-19 RT-PCR Kit (LabGenomics Co., Ltd)
- Rheonix COVID-19 MDx Assay (Rheonix, Inc.)
- LabGun COVID-19 RT-PCR Kit (LabGenomics Co., Ltd.)
- Platelia SARS-CoV-2 Total Ab assay (Bio-Rad Laboratories)
Updated
Emergency Use Authorizations:
- Appendix B-Ventilators
- Xpert Xpress SARS-CoV-2 test (Cepheid)
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack
(Ortho-Clinical Diagnostics, Inc.)
NOTICE
OF MEETING POSTPONEMENT: June 9, 2020 - Ophthalmic Devices Panel
of the Medical Devices Advisory Committee
Class
I Recall: Vascular Solutions, Inc. Recalls Langston Dual Lumen Catheter
Due to Risk of Separation During Use
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
|
|
April 29, 2020
New
Emergency Use Authorizations:
- SARS-CoV-2 Antibody Tests
Consumer
Information on: FoundationOne CDx – P170019/S013
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Federal
Register: Postponement: Ophthalmic Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting
|
|
April 28, 2020
Updated
Emergency Use Authorizations:
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors,
and Ventilator Accessories
- VitalPatch (VitalConnect, Inc.)
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
|
|
April 27, 2020
New
Emergency Use Authorizations:
- VitalPatch (VitalConnect, Inc.)
- Abbott Laboratories Inc.
- U-TOP COVID-19 Detection Kit (SEASUN BIOMATERIALS)
- SARS-CoV-2 Assay (Nationwide Children’s Hospital)
Updated
Emergency Use Authorizations:
- Laboratory Corporation of America (LabCorp)
- DiaSorin Molecular LLC
- NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc)
FAQs
on Ventilators (Updated)
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
FAQs
on Emergency Use Authorizations (EUAs) for Medical Devices During
the COVID-19 Pandemic
Global
Unique Device Identification Database (GUDID) (Updated)
- GUDID Data Elements Reference Table
- UDI and GUDID Technical Documents - HL7 SPL Implementation Files
UPDATE:
Potential Risks with Liquid-filled Intragastric Balloons - Letter
to Health Care Providers
FDA
In Brief: Postmarket Update on Liquid-filled Intragastric Balloons
Surgical
Mask and Gown Conservation Strategies - Letter to Health Care Providers
(Updated)
Medical
Glove Conservation Strategies: Letter to Health Care Providers (Updated)
Consumer
Information on: The cobas HPV for use on the cobas 6800/8800 Systems
– P190028
Federal
Register: Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Accreditation
Scheme for Conformity Assessment Pilot Program
|
April 26, 2020
FAQs
on the Emergency Use Authorization for Face Masks (Non-Surgical) |
|
April 25, 2020
New
Emergency Use Authorizations:
- DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG
- Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products
Anti-SARS-CoV-2 IgG Reagent Pack
- Autiobio Diagnostics Co. Ltd. Anti-SARS-CoV-2 Rapid Test
- Southwest Regional PCR Laboratory LLC. dba MicroGen DX COVID-19
Key
- Ultimate Dx Laboratory UDX SARS-CoV-2 Molecular Assay
- AIT Laboratories SARS-CoV-2 Assay
Updated
Emergency Use Authorizations:
- Face Masks (non-surgical) - Reissuance
- Hologic, Inc. Panther Fusion SARS-CoV-2 Assay - Added Letter Granting
EUA Amendment(s) (April 24, 2020)
|
|
April 24, 2020
Updated
Emergency Use Authorizations:
- Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators Manufactured in China
- Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGI
Genomics Co. Ltd)
- NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.)
- ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection
Kit (ScienCell Research Laboratories)
- SARS-CoV-2 Fluorescent PCR Kit (Maccura Biotechnology (USA) LLC)
- SARS-CoV-2 Test (Exact Sciences Laboratories)
Enforcement
Policy for Remote Digital Pathology Devices During the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry,
Clinical Laboratories, Healthcare Facilities, Pathologists, and
Food and Drug Administration Staff
FDA
Activities Related to Essure (Updated)
Problems
Reported with Essure (Updated)
FDA
News Release: FDA Provides Updates on Adverse Event Reports and
Postmarket Activities Associated with Essure
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated 4/24)
|
|
April 23, 2020
New
Emergency Use Authorizations:
- Extracorporeal Blood Purification (EBP) (Baxter Healthcare Corporation)
- ALung Technologies, Inc., Hemolung RAS
- STANDARD M nCoV Real-Time Detection Kit (SD Biosensor, Inc.)
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated 4/23)
Enforcement
Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used
to Support Patient Monitoring During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency - Guidance for Industry and Food
and Drug Administration Staff
Enforcement
Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19)
Public Health Emergency - Guidance for Industry and Food and Drug
Administration Staff
Non-contact
Infrared Thermometers
|
|
April 22, 2020
New
Emergency Use Authorizations:
- IntelliVue Patient Monitors (Philips Medizin Systeme Boeblingen
GmbH)
- altona Diagnostics GmbH (RealStar SARS-CoV-2 RT-PCR Kit U.S)
- Diatherix Eurofins Laboratory (SARS-CoV-2 PCR Test)
FAQs
on Ventilators
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190025
added)
|
|
April 21, 2020
New
Emergency Use Authorizations:
- SARS-CoV-2 Molecular Detection Assay (Mayo Clinic Laboratories,
Rochester, MN)
- Sterilucent, Inc. Sterilization System
- Allplex 2019-nCoV Assay (Seegene, Inc.)
Updated
Emergency Use Authorizations:
- TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors,
and Ventilator Accessories
- ID NOW COVID-19 (Abbott Diagnostics Scarborough, Inc.)
- cobas SARS-CoV-2 (Roche Molecular Systems, Inc. (RMS))
Ventilator
EUA Interactive Review Template
Nonbinding
Feedback After Certain FDA Inspections of Device Establishments
- Guidance for Industry and Food and Drug Administration Staff
Press
Release: Coronavirus (COVID-19) Update: FDA Authorizes First Test
for Patient At-Home Sample Collection
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Federal
Register: Nonbinding Feedback After Certain Food and Drug Administration
Inspections of Device Establishments
|
|
April 20, 2020
New
Emergency Use Authorizations:
- Trax Management Services Inc. PhoenixDx 2019-CoV
Updated
Emergency Use Authorizations:
- Laboratory Corporation of America (LabCorp) COVID-19 RT-PCR Test
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Presentation
and Transcript added for Town Hall Series - Immediately in Effect
Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 15,
2020
|
April 19, 2020
New
Emergency Use Authorizations:
- Face Masks (non-surgical) |
April 18, 2020
New
Emergency Use Authorizations:
- Fosun Pharma USA Inc. Fosun COVID-19 RT-PCR Detection Kit
- OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit |
|
April 17, 2020
New
Emergency Use Authorizations:
- GenoSensor, LLC GS™ COVID-19 RT-PCR KIT
- KorvaLabs Inc. Curative-Korva SARS-Cov-2 Assay
- Exact Sciences Laboratories SARS-CoV-2 Test
- ExThera Medical Corporation Extracorporeal Blood Purification
(EBP) Device
Updated
Emergency Use Authorizations:
Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
Manufactured in China
Consumer
Information on: Ventana Medical Systems CINtec PLUS Cytology - P190024
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190028
added)
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Important
Information on the Use of Serological (Antibody) Tests for COVID-19
- Letter to Health Care ProvidersImportant Information on the Use
of Serological (Antibody) Tests for COVID-19 - Letter to Health
Care Providers
FDA
Fact Sheet - Serological Testing for Antibodies to SARS-CoV-2 Infection
|
|
April 16, 2020
New
Emergency Use Authorizations:
Mount Sinai Laboratory
- CirrusDx Laboratories
- Hackensack University Medical Center (HUMC) Molecular Pathology
Laboratory
Updated
Emergency Use Authorizations:
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors,
and Ventilator Accessories
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Enforcement
Policy for Telethermographic Systems During the Coronavirus Disease
2019 (COVID-19) Public Health Emergency - Guidance for Industry
and Food and Drug Administration Staff
Federal
Register: Medical Device User Fee Amendments for Fiscal Years 2023
Through 2027; Public Meeting; Request for Comments; Postponement
|
|
April 15, 2020
New
Emergency Use Authorizations
- Chembio Diagnostic System, Inc
- Ortho Clinical Diagnostics, Inc.
- Laboratory Corporation of America (LabCorp) (Updated)
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors,
and Ventilator Accessories (Updated)
- Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle
- Lungpacer Medical, Inc. Diaphragm Pacing Therapy System (DPTS)
- Maccura Biotechnology (USA) LLC SARS-CoV-2 Fluorescent PCR Kit
Updated
Emergency Use Authorizations:
- Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators Manufactured in China
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Federal
Register: Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Submission
of Information on Pediatric Uses of Medical Devices
Federal
Register: Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Drug Administration Safety Communication
Readership Survey; Withdrawal of Notice
|
|
April 14, 2020
New
Emergency Use Authorizations:
- Integrity Laboratories SARS-CoV-2 Assay
- Pathology/Laboratory Medicine Lab of Baptist Hospital Miami COVID-19
RT-PCR Test
- Synapse Biomedical, Inc. TransAeris Diaphragmatic Pacing Therapy
System (DPTS)
Updated
Emergency Use Authorizations:
- Simplexa COVID-19 Direct assay - Letter Granting EUA Amendment(s)
(April 13, 2020)
- Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators Manufactured in China
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
- Exhibit 1: Authorized Respirators
Enforcement
Policy for Digital Health Devices For Treating Psychiatric Disorders
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Guidance for Industry and Food and Drug Administration Staff
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
|
|
April 13, 2020
New
Emergency Use Authorizations:
- B. Braun Space and Outlook Pumps
Updated
Emergency Use Authorizations:
- Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators Manufactured in China
- Face Shields
- Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators
- Exhibit 1: Authorized Respirators
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
FAQs
on Home-use Blood Glucose Meters Utilized Within Hospitals During
the COVID-19 Pandemic
Presentation
and Transcript posted for Webinar - Enforcement Policy for Personal
Protective Equipment (PPE) During COVID-19: Immediately in Effect
Guidance
|
April 12, 2020
New
Emergency Use Authorizations:
- Advanced Sterilization Products (ASP) STERRAD Sterilization System |
|
April 11, 2020
FAQs
on Diagnostic Testing for SARS-CoV-2 - Added Serology/Antibody Test
FAQs
New
Emergency Use Authorizations:
- UNC Health SARS-CoV-2 real-time RT-PCR test
|
|
April 10, 2020
New
Emergency Use Authorizations:
- Face Shields
- STERIS Sterilization Systems for Decontamination of N95 Respirators
- CytoSorbent, Inc. Extracorporeal Blood Purification (EBP) Device
- iAMP COVID-19 Detection Kit (Atila BioSystems, Inc.)
- Orig3n 2019 Novel Coronavirus (COVID-19) Test (Orig3n, Inc.)
- ThermoFisher - Applied Biosystems TaqPath COVID-19 Combo Kit (Rutgers
Clinical Genomics Laboratory-Rutgers University)
- SDI SARS-CoV-2 Assay (Specialty Diagnostic (SDI) Laboratories)
Updated
Emergency Use Authorizations:
- Xpert Xpress SARS-CoV-2 test - Letter Granting EUA Amendment(s)
(April 8, 2020)
- Appendix A: Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators Manufactured in China
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
|
|
April 9, 2020
CDRH
Petitions (Updated)
FAQs
on Shortages of Surgical Masks and Gowns (Updated)
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Updated
Emergency Use Authorizations:
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors,
and Ventilator - Accessories
Terumo BCT Inc. and Marker Therapeutics AG Extracorporeal Blood
Purification (EBP) Devices
|
|
April 8, 2020
New
Emergency Use Authorizations:
- QuantiVirus SARS-CoV-2 Test Kit
- SARS-CoV-2 PCR Assay (Stanford Health Care Clinical Virology Laboratory)
- BD SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and
Company)
Updated
Emergency Use Authorizations
- Appendix B: Authorized Ventilators, Ventilator Tubing Connectors,
and Ventilator Accessories
Presentation
and Transcript added for Town Hall Series - Immediately in Effect
Guidance on Coronavirus (COVID-19) Diagnostic Tests - April 1, 2020
Consumer
Information on: VENOUS WALLSTENT - P980033/S050
|
|
April 7, 2020
Class
I Recall: Boston Scientific Corporation Recalls Imager II Angiographic
Catheters Due to Tip Detachment
Consumer
Information on: Nucleus 24 Cochlear Implant System - P970051/S172
Emergency
Use Authorizations - Added Smart Detect SARS-CoV-2 rRT-PCR Kit (InBios
International, Inc.); updated Ventilators, anesthesia gas machines
modified for use as ventilators, and positive pressure breathing
devices modified for use as ventilators (collectively referred to
as "ventilators"), ventilator tubing connectors, and ventilator
accessories - Appendix B; updated Non-NIOSH-Approved Disposable
Filtering Facepiece Respirators Manufactured in China - Appendix
A
|
|
April 6, 2020
Emergency
Use Authorizations - Added Imported, Non-NIOSH-Approved Disposable
Filtering Facepiece Respirators - Exhibit 1: Authorized Respirators,
Viracor SARS-CoV-2 assay, and Gnomegen COVID-19 RT-Digital PCR Detection
Kit
Enforcement
Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary
Bypass Devices During the Coronavirus Disease 2019 (COVID-19) Public
Health Emergency - Guidance for Industry and Food and Drug Administration
Staff
Enforcement
Policy for Remote Ophthalmic Assessment and Monitoring Devices During
the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Guidance for Industry and Food and Drug Administration Staff
|
April 5, 2020
Emergency
Use Authorizations - Added MGH COVID-19 qPCR assay, Massachusetts
General Hospital
Enforcement
Policy for Infusion Pumps and Accessories During the Coronavirus Disease
2019 (COVID-19) Public Health Emergency - Guidance for Industry and
Food and Drug Administration Staff
FAQs
on 3D Printing of Medical Devices, Accessories, Components, and Parts
During the COVID-19 Pandemic (Updated)
FAQs
on Shortages of Surgical Masks and Gowns (Updated)
N95
Respirators and Surgical Masks (Face Masks) (Updated)
Medical
Devices and the COVID-19 (Coronavirus) Pandemic (Updated)
Surgical
Mask and Gown Conservation Strategies - Letter to Healthcare Providers
(Updated) |
April 4, 2020
Enforcement
Policy for Clinical Electronic Thermometers During the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry
and Food and Drug Administration Staff
Protecting
the Health and Safety of Medical Device Manufacturing Personnel During
COVID-19
Updated
Letter to Industry on COVID-19 - April 4, 2020 |
April 3, 2020
Webinar
- Enforcement Policy for Personal Protective Equipment (PPE) During
COVID-19: Immediately in Effect Guidance - April 6, 2020
Emergency
Use Authorizations - Added SARS-Cov-2 Assay (Diagnostic Molecular
Laboratory - Northwestern Medicine), SARS-CoV-2 RT-PCR test (Infectious
Disease Diagnostics Laboratory - Children’s Hospital of Philadelphia),
Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (Co-Diagnostics,
Inc.), ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR)
Detection Kit (ScienCell Research Laboratories), and ARIES SARS-CoV-2
Assay (Luminex Corporation)
Ventilators,
anesthesia gas machines modified for use as ventilators, and positive
pressure breathing devices modified for use as ventilators (collectively
referred to as "ventilators"), ventilator tubing connectors,
and ventilator accessories (Appendix B Updated)
FAQs
on Shortages of Surgical Masks and Gowns (Updated)
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN180030
added) |
April 2, 2020
Enforcement
Policy for Face Masks and Respirators During the Coronavirus Disease
(COVID-19) Public Health Emergency (Revised) - Guidance for Industry
and Food and Drug Administration Staff
Emergency
Use Authorizations - Added BioGX SARS-CoV-2 Reagents for BD MAX System
(Becton, Dickinson & Company (BD))
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Consumer
Information on: Alto™ Abdominal Stent Graft System - P120006/S031
Class
I Recall: LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy
Catheter Due to Balloon Deflation and Separation Issue
Federal
Register: Medical Device User Fee Amendments for Fiscal Years 2023
through 2027
Meeting
Notice: June 9, 2020 Ophthalmic Devices Panel of the Medical Devices
Advisory Committee Meeting Announcement
FDA-ARGOS
SARS-CoV-2 Reference Grade Sequence Data
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Federal
Register: Medical Devices; Technical Amendment
Federal
Register: Medical Devices; Technical Amendment
Federal
Register: Reclassification of Certain Hepatitis C Virus Antibody Assays
Devices, To Be Renamed Hepatitis C Virus Antibody Tests
Federal
Register: Reclassification of Nucleic Acid-Based Hepatitis C Virus
Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis
C Virus Ribonucleic Acid Tests
Medical
Devices and the COVID-19 (Coronavirus) Pandemic
MQSA
National Statistics
Device
Advice: Comprehensive Regulatory Assistance (Updated) |
March 31, 2020
Emergency
Use Authorizations - Added Yale New Haven Hospital, Clinical Virology
Laboratory, and Laboratories Who Have Developed a Molecular-Based
Test (LDTs) for Coronavirus Disease 2019 (COVID-19)
Federal
Register: Ophthalmic Devices Panel of the Medical Devices Advisory
Committee |
March 30, 2020
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Enforcement
Policy for Gowns, Other Apparel, and Gloves During the Coronavirus
Disease (COVID-19) Public Health Emergency - Guidance for Industry
and Food and Drug Administration Staff
Class
I Recall: Medtronic Recalls Pipeline Flex Embolization Devices Due
to Risk of Device Fracture
Class
I Recall: CME America Recalls BodyGuard Infusion Pump System Due to
Risk of Over-, and Under-infusion
Webcast
Archive posted for Public Workshop - Medical Extended Reality: Toward
Best Evaluation Practices for Virtual and Augmented Reality in Medicine,
March 5, 2020
Presentation
posted for the March 25, 2020 Virtual Town Hall Series on the Immediately
in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests
Emergency
Use Authorizations - Added QIAstat-Dx Respiratory SARS-CoV-2 Panel
(QIAGEN GmbH), and NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.) |
March 29, 2020
Enforcement
Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During
the Coronavirus Disease 2019 (COVID-19) Public Health Emergency -
Guidance for Industry and Food and Drug Administration Staff
Emergency
Use Authorizations - Added Battelle Decontamination System |
March 28, 2020
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated) |
March 27, 2020
Emergency
Use Authorizations - Added ID NOW COVID-19, NxTAG CoV Extended Panel
Assay, and Letters Granting EUA Amendment(s) to Quest SARS-CoV-2 rRT-PCR
and Simplexa COVID-19 Direct assay
Center
for Devices and Radiological Health (CDRH) Appeals Processes: Questions
and Answers About 517A - Guidance for Industry and Food and Drug Administration
Staff
Virtual
Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19)
Diagnostic Tests - April 1, 2020
Federal
Register: Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 053 |
March 26, 2020
FAQs
on 3D Printing of Medical Devices, Accessories, Components, and Parts
During the COVID-19 Pandemic
Digital
Health Policies and Public Health Solutions for COVID-19
Public
Workshop - Artificial Intelligence in Radiological Imaging: Extension
of Comment Period
Emergency
Use Authorizations - Added Real-Time Fluorescent RT-PCR Kit for Detecting
SARS-2019-nCoV |
March 25, 2020
Enforcement
Policy for Face Masks and Respirators During the Coronavirus Disease
(COVID-19) Public Health Emergency - Guidance for Industry and Food
and Drug Administration Staff
Emergency
Use Authorizations - Added Ventilators and AvellinoCoV2 test |
March 24, 2020
Emergency
Use Authorizations - Added Imported, Non-NIOSH-Approved Disposable
Filtering Facepiece Respirators and PerkinElmer New Coronavirus Nucleic
Acid Detection Kit
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
FDA
Statement: Coronavirus (COVID-19) Update: FDA takes action to increase
U.S. supplies through instructions for PPE and device manufacturers |
March 23, 2020
Letter
to Industry on COVID-19
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Emergency
Use Authorizations - Accula SARS-Cov-2 Test (Mesa Biotech Inc.) and
BioFire COVID-19 Test (BioFire Defense, LLC)
Consumer
Information on: Abbott InfinityTM DBS Neurostimulation System - P140009/S039 |
March 22, 2020
Enforcement
Policy for Ventilators and Accessories and Other Respiratory Devices
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Guidance for Industry and Food and Drug Administration Staff
Ventilator
Supply Mitigation Strategies - Letter to Health Care Providers |
March 21, 2020
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
Emergency
Use Authorizations - Added Xpert Xpress SARS-CoV-2 test (Cepheid) |
March 20, 2020
Emergency
Use Authorizations - Added Primerdesign Ltd COVID-19 genesig Real-Time
PCR assay (Primerdesign Ltd)
Enforcement
Policy for Non-Invasive Remote Monitoring Devices Used to Support
Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 )
Public Health Emergency - Guidance for Industry and Food and Drug
Administration Staff
News
Release: Coronavirus (COVID-19) Update: FDA allows expanded use of
devices to monitor patients’ vital signs remotely
Virtual
Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19)
Diagnostic Tests - March 25, 2020
FAQs
on Shortages of Medical Gloves
Medical
Glove Conservation Strategies: Letter to Health Care Providers
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated) |
March 19, 2020
Emergency
Use Authorizations - Added ePlex SARS-CoV-2 Test (GenMark Diagnostics,
Inc.) and Simplexa COVID-19 Direct (DiaSorin Molecular LLC)
MQSA
Inspection Information Related to COVID-19
POSTPONED:
Public Workshop - Using Patient Preference Information in Medical
Device Regulatory Decisions: Benefit-Risk and Beyond - March 31, 2020 |
March 18, 2020
Emergency
Use Authorizations - Added Abbott RealTime SARS-CoV-2 assay (Abbott
Molecular)
Consumer
Information on: LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX
Control Anti-HBs, LIAISON® XL MUREX Anti-HBs Verifiers - P180039
Class
I Recall: CME America Recalls BodyGuard Microset Infusion Sets for
the BodyGuard Infusion Pump System Due to Risk of Under-Infusion |
March 17, 2020
Emergency
Use Authorizations - Added Quest SARS-CoV-2 rRT-PCR (Quest Diagnostics
Infectious Disease, Inc.) and Lyra SARS-CoV-2 Assay (Quidel Corp.)
FAQs
on Diagnostic Testing for SARS-CoV-2 (Updated)
POSTPONED:
April 16, 2020 Circulatory System Devices Panel of the Medical Devices
Advisory Committee meeting |
March 16, 2020
Emergency
Use Authorizations - Added COVID-19 RT-PCR Test (Laboratory Corporation
of America) and Panther Fusion SARS-CoV-2 (Hologic, Inc.)
Policy
for Diagnostic Tests for Coronavirus Disease-2019 during the Public
Health Emergency - Immediately in Effect Guidance for Clinical Laboratories,
Commercial Manufacturers, and Food and Drug Administration Staff
MQSA
Facility Adverse Event and Action Report - March 13, 2020: The Breast
Institute at JFK Medical Center North Campus |
March 13, 2020
Meeting
Notice: April 16, 2020 Circulatory System Devices Panel of the Medical
Devices Advisory Committee
MQSA
Facility Adverse Event and Action Report - March 13, 2020: The Breast
Institute at JFK Medical Center North Campus
Updated:
FAQs on Diagnostic Testing for SARS-CoV-2
Presentation
added to Webinar - Policy for Diagnostics Testing in Laboratories
Certified to Perform High Complexity Testing under CLIA prior to Emergency
Use Authorization for Coronavirus Disease-2019 during the Public Health
Emergency - March 2, 2020
Emergency
Use Authorizations - Added TaqPath COVID-19 Combo Kit (Thermo Fisher
Scientific, Inc.) |
March 12, 2020
Emergency
Use Authorizations - Added cobas SARS-CoV-2 (Roche Molecular Systems,
Inc.)
Federal
Register: Circulatory System Devices Panel of the Medical Devices
Advisory Committee
Updated: FAQs on Diagnostic Testing for SARS-CoV-2
Consumer
Information on: AcrySof™ IQ Vivity™ Extended Vision Intraocular
Lens (IOL) (Model DFT015), AcrySof™ IQ Vivity™ Toric Extended
Vision IOLs (DFT315, DFT415, DFT515), AcrySof™ IQ Vivity™
Extended Vision UV Absorbing IOL (DAT015), and AcrySof™ IQ Vivity™
Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515) -
P930014/S126 |
March 11, 2020
510(k)
Third Party Review Program - Guidance for Industry, Food and Drug
Administration Staff, and Third Party Review Organizations
Webinar
- 510(k) Third Party Review Program: Final Guidance - April 16, 2020
Surgical
Mask and Gown Conservation Strategies - Letter to Healthcare Providers
FAQs
on Shortages of Surgical Masks and Gowns
Federal
Register: The 510(k) Third Party Review Program |
March 10, 2020
Updated:
FAQs on Diagnostic Testing for SARS-CoV-2
Updated
with Four New Modules: CDRH Learn Course List (Spanish) |
March 9, 2020
Premarket
Notification (510(k)) Submissions for Electrosurgical Devices for
General Surgery - Guidance for Industry and Food and Drug Administration
Staff
Updated:
FAQs on Diagnostic Testing for SARS-CoV-2 |
March 6, 2020
Class
I Recall: Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris
System Infusion Pumps Due to Software and System Errors
Transcript
added to: Webinar - Policy for Diagnostics Testing in Laboratories
Certified to Perform High Complexity Testing under CLIA prior to Emergency
Use Authorization for Coronavirus Disease-2019 during the Public Health
Emergency - March 2, 2020
Emergency
Use Authorizations: Authorized NIOSH-approved Respirators that have
been held Beyond their Manufacturer-intended Shelf Life or Expiration
Date |
March 5, 2020
Virtual
Town Hall - Policy for Diagnostics Testing in Laboratories Certified
to Perform High Complexity Testing under CLIA prior to Emergency Use
Authorization for Coronavirus Disease-2019 during the Public Health
Emergency - Immediately in Effect Guidance - March 6, 2020
Public
Meeting - Medical Device User Fee Amendments for Fiscal Years 2023
Through 2027 - April 7, 2020
Federal
Register: Medical Device User Fee Amendments for Fiscal Years 2023
Through 2027
Federal
Register: Policy for Diagnostics Testing in Laboratories Certified
to Perform High Complexity Testing Under the Clinical Laboratory Improvement
Amendments Prior to Emergency Use Authorization for Coronavirus Disease-2019
During the Public Health Emergency; Immediately in Effect Guidance
for Clinical Laboratories and Food and Drug Administration Staff;
Availability |
March 4, 2020
Updated:
Medical Device Bans
FDA
News Release: FDA Takes Rare Step to Ban Electrical Stimulation Devices
for Self-Injurious or Aggressive Behavior
Federal
Register: Banned Devices: Electrical Stimulation Devices for Self-Injurious
or Aggressive Behavior |
March 3, 2020
N95
Respirators and Surgical Masks (Face Masks)
Soft
(Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for
Safety and Performance Based Pathway - Draft Guidance for Industry
and Food and Drug Administration Staff
Federal
Register: Soft (Hydrophilic) Daily Wear Contact Lenses--Performance
Criteria for Safety and Performance Based Pathway
SweynTooth
Cybersecurity Vulnerabilities May Affect Certain Medical Devices:
FDA Safety Communication
FDA
News Release: FDA Informs Patients, Providers and Manufacturers About
Potential Cybersecurity Vulnerabilities in Certain Medical Devices
with Bluetooth Low Energy |
March 2, 2020
Emergency
Use Authorizations - NIOSH-Approved Disposable Filtering Facepiece
Respirators for Use in Health Care Settings During Response to the
COVID-19 Public Health Emergency
Bone
Anchors - Premarket Notification (510(k)) Submissions - Guidance for
Industry and Food and Drug Administration Staff
MQSA
National Statistics
Presentations
added to Workshop - Evolving Role of Artificial Intelligence in Radiological
Imaging - February 25-26, 2020
Federal
Register: Bone Anchors--Premarket Notification (510(k)) Submissions |
February 29, 2020
Policy
for Diagnostics Testing in Laboratories Certified to Perform High
Complexity Testing under CLIA prior to Emergency Use Authorization
for Coronavirus Disease-2019 during the Public Health Emergency -
Immediately in Effect Guidance for Clinical Laboratories and Food
and Drug Administration Staff
Accelerated
Emergency Use Authorization Template for SARS-COV-2 (covid-19) Molecular
Testing of Respiratory Specimens in CLIA Certified High-Complexity
Laboratories (Word - 128kb)
Webinar
- Policy for Diagnostics Testing in Laboratories Certified to Perform
High Complexity Testing under CLIA prior to Emergency Use Authorization
for Coronavirus Disease-2019 during the Public Health Emergency -
March 2, 2020
Emergency
Use Authorizations - New York SARS-CoV-2 Real-time Reverse Transcriptase
(RT)-PCR Diagnostic Panel (Wadsworth Center, NYSDOH) |
February 27, 2020
Class
I Recall: King Systems Recalls King Vision Video Laryngoscope Adapter
Size ½ Due to a Display of The Reversed Image
Potential
Risks Associated With The Use of Ozone and Ultraviolet (UV) Light
Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication
Press
Release: FDA Reminds Patients that Devices Claiming to Clean, Disinfect
or Sanitize CPAP Machines Using Ozone Gas or UV Light Have Not Been
FDA Authorized |
February 26, 2020
The
FDA Announces Voluntary eSTAR Pilot Program to Streamline 510(k) Preparation
and Review
FDA
In Brief: FDA launches new interactive, PDF-based, template to promote
greater efficiency and consistency in preparation and review of 510(k)
medical device applications
Federal
Register: Improving 510(k) Submission Preparation and Review: Voluntary
Electronic Submission Template and Resource Pilot Program
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190020
added) |
|
February 25, 2020
UPDATE:
Reduce the Risk of Cardiac Surgery Infection While Using the LivaNova
Heater-Cooler System 3T: FDA Safety Communication
Class
I Recall - Tytek Medical Recalls TM-317 PneumoDart-Pneumothorax
Needle Due to Fully and Partially Blocked Needles
Product
Labeling for Laparoscopic Power Morcellators - Draft Guidance for
Industry and Food and Drug Administration Staff
Recommendations
for Dual 510(k) and CLIA Waiver by Application Studies - Guidance
for Industry and Food and Drug Administration Staff
Recommendations
for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver
Applications for Manufacturers of In Vitro Diagnostic Devices -
Guidance for Industry and Food and Drug Administration Staff
Webinar
- Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications
Final Guidances - April 14, 2020
Updated:
Clinical Laboratory Improvement Amendments (CLIA)
UPDATE:
The FDA recommends performing contained morcellation in women when
laparoscopic power morcellation is appropriate
Federal
Register: Product Labeling for Laparoscopic Power Morcellators
Federal
Register: Recommendations for Clinical Laboratory Improvement Amendments
of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic
Devices
Federal
Register: Recommendations for Dual 510(k) and Clinical Laboratory
Improvement Amendments Waiver by Application Studies
Press
Release: FDA Takes New Steps to Increase the Safety of Laparoscopic
Power Morcellators when used in Gynecologic Surgeries
|
February 24, 2020
eeting
Notice: April 23-24, 2020 Orthopaedic and Rehabilitation Devices Panel
of the Medical Devices Advisory Committee
FY2020
1st Quarter MDUFA IV Performance Report
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190023
added) |
February 21, 2020
Federal
Register: Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee |
February 20, 2020
Table
of Pharmacogenetic Associations
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN180017
and DEN190040 added)
Federal
Register: Medical Devices; Reports of Corrections and Removals
Federal
Register: Annual Reporting for Custom Device Exemption |
February 19, 2020
Class
I Recall: Teleflex Medical Recalls Comfort Flo Humidification Systems
Due to Malfunction That May Cause Water to Enter Airway
Class
I Recall: Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary
Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm
and 5.00mm) to Deflate
Class
I Recall: ResMed Recalls Stellar 100 and 150 Non-invasive and Invasive
Ventilators Due to Sound Alarm Failure
Mammography
Facility Adverse Event and Action Report - February 19, 2020: Winchester
Medical Center - Diagnostic Center |
February 18, 2020
Public
Workshop - Using Patient Preference Information in Medical Device
Regulatory Decisions: Benefit-Risk and Beyond - March 31, 2020 |
February 14, 2020
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190034
added)
Workshop
- Towards Good Simulation Practices in Health Technologies - April
13-15, 2020
Consumer
Information on Bulkamid Urethral Bulking System - P170023 |
February 12, 2020
Peripheral
Vascular Atherectomy Devices - Premarket Notification [510(k)] Submissions
- Guidance for Industry and Food and Drug Administration Staff
Class
I Recall: Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin
Dosing
Three
New CDRH Learn Modules: Overview of the 510(k) Process: Guide for
Third Party Reviewers, Deficiency Writing for Third Party Reviewers,
and Deficiency Writing for Third Party Reviewers: Examples
Federal
Register: Peripheral Vascular Atherectomy Devices--Premarket Notification
Submissions
Federal
Register: Request for Nominations:Individuals and Industry Organizations
for the Patient Engagement Advisory Committee |
February 11, 2020
Mammography
Facility Adverse Event and Action Report - February 11, 2020: Women’s
Care Florida OB & GYN Specialists
Mammography
Facility Adverse Event and Action Report - February 11, 2020: Raleigh
Radiology - Blue Ridge
Public
Workshop - Detecting Circulating Tumor DNA for Cancer Screening -
March 9, 2020
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN190038
and DEN190040 added) |
February 10, 2020
Cell
Phone Safety: Web Updates
Review
of Published Literature between 2008 and 2018 of Relevance to Radiofrequency
Radiation and Cancer – PDF (1.1MB)
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN180056
added) |
February 7, 2020
Class
I Recall: GE Healthcare Recalls Carestation 600 Series Anesthesia
Systems Due to Loss of Mechanical Ventilation
Federal
Register: Electronic Submission Process for Voluntary Allegations
to the Center for Devices and Radiological Health
Federal
Register: Testing Communications on Medical Devices and Radiation-Emitting
Products |
February 6, 2020
Summary
Minutes posted for November 6-7, 2019 General Hospital and Personal
Use Devices Panel of the Medical Devices Advisory Committee Meeting
Federal
Register: Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Premarket
Approval of Medical Devices
Federal
Register: Immunology and Microbiology Devices; Classification of Human
Immunodeficiency Virus Drug Resistance Genotyping Assay Using Next
Generation Sequencing Technology |
February 5, 2020
Updated:
Medical Gowns
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN180062
added) |
February 4, 2020
Emergency
Use Authorizations - Added CDC 2019-nCoV Real-Time RT-PCR Diagnostic
Panel (CDC)
Accreditation
Scheme for Conformity Assessment (ASCA) - Annual Report 2019 (PDF
- 6.72MB)
Class
I Recall: GE Healthcare Recalls CARESCAPE Respiratory Modules Due
to Incorrect Oxygen Values |
February 3, 2020
MQSA
National Statistics |
January 29, 2020
Federal
Register: Request for Nominations for Voting Members for the Patient
Engagement Advisory Committee |
January 28, 2020
Class
I Recall: Distributor Teleflex Recalls the Galemed Babi.Plus Pressure
Relief Manifolds Due to Dislodged Valve
Ethylene
Oxide Sterilization Facility Updates
Public
Meeting - Food and Drug Administration’s Communications About
the Safety of Medical Devices - April 1, 2020
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN180014
and DEN180058 added) |
January 27, 2020
Arthroscopy
Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification
(510(k)) Submissions - Draft Guidance for Industry and Food and Drug
Administration Staff
Federal
Register: Arthroscopy Pump Tubing Sets Intended for Multiple Patient
Use--Premarket Notification (510(k)) Submissions |
January 24, 2020
Cybersecurity
Vulnerabilities in Certain GE Healthcare Clinical Information Central
Stations and Telemetry Servers: Safety Communication |
January 23, 2020
CDRH's
Experiential Learning Program |
January 22, 2020
Flow
Re-Direction Endoluminal Device (FRED®) System - P180027
Federal
Register: Agency Information Collection Activities; Proposed Collection;
Comment Request; Electronic Products |
January 21, 2020
Clinical
Performance Assessment: Considerations for Computer-Assisted Detection
Devices Applied to Radiology Images and Radiology Device Data in Premarket
Notification (510(k)) Submissions - Guidance for Industry and FDA
Staff
Evaluation
of Automatic Class III Designation (De Novo) Summaries (DEN170022
and DEN170073 added)
Federal
Register: Classification of the Radiological Computer Aided Triage
and Notification Software
Federal
Register: Classification of the Radiological Computer-Assisted Diagnostic
Software for Lesions Suspicious for Cancer
Federal
Register: Reclassification of Medical Image Analyzers |
January 16, 2020
Public
Workshop - Medical Extended Reality: Toward Best Evaluation Practices
for Virtual and Augmented Reality in Medicine - March 5, 2020
Press
Release: Statement on quality issues with certain Cardinal Health
surgical gowns and packs
Federal
Register: Requests for Nominations: Voting Members on a Public Advisory
Committee; Technical Electronic Product Radiation Safety Standards
Committee |
|
January 15, 2020
Mammography
Facility Adverse Event and Action Report - January 14, 2020: North
Jersey Radiology Center
|
|
January 13, 2020
Consumer
Information on: LIAISON® XL MUREX Anti-HBc, LIAISON® XL
MUREX Control Anti-HBc - P180038
New
CDRH Learn Modules: Production and Process Controls Part 2, Importing
Medical Devices Into the United States, and Electronic Product Certification
and Quality Testing Programs
Federal
Register: Exemption From Premarket Notification; Class II Devices;
Powered Wheeled Stretcher
|
See the current
MedSun newsletter at the FDA website for Recalls and Safety Alerts,
Highlighted Reports, and Links to FDA/CDRH Databases and Other Information
Sources.
|
|
