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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.
| November 15, 2024 - FDA
Roundup: November 15, 2024 |
| November 14, 2024 - FDA
Approves First Gene Therapy for Treatment of Aromatic L-amino Acid
Decarboxylase Deficiency |
| November 8, 2024 - FDA
Roundup: November 8, 2024 |
| November 7, 2024 - FDA
Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant
Active Ingredient After Extensive Review |
| November 5, 2024 - FDA
Roundup: November 5, 2024 |
| November 1, 2024 - FDA
Roundup: November 1, 2024 |
| October 29, 2024 - FDA
Roundup: October 29, 2024 |
| October 25, 2024 - FDA
Roundup: October 25, 2024 |
| October 22, 2024 - $76
Million in Illegal E-Cigarettes Seized in Joint Federal Operation |
| October 18, 2024 - FDA
Roundup: October 18, 2024 |
| October 15, 2024 - FDA
Roundup: October 15, 2024 |
| October 11, 2024 - FDA
Roundup: October 11, 2024 |
| October 11, 2024 - FDA
Approves New Treatment for Hemophilia A or B |
| October 8, 2024 - Federal
Court Enters Consent Decree Against Rizo Lopez Foods Inc. Following
Multistate Outbreak of Listeriosis Linked to Queso Fresco and Cotija
Cheese Products |
| October 7, 2024 - FDA
Authorizes Marketing of First Home Flu and COVID-19 Combination Test
Outside of Emergency Use Authorities |
| October 4, 2024 - FDA
Roundup: October 4, 2024 |
| October 1, 2024 - FDA’s
Unified Human Foods Program, New Model for Field Operations, and Other
Modernization Efforts Go into Effect |
| October 1, 2024 - FDA
Roundup: October 1, 2024 |
| September 27, 2024 - FDA
Roundup: September 27, 2024 |
| September 26, 2024 - FDA
Approves Drug with New Mechanism of Action for Treatment of Schizophrenia |
| September 24, 2024 - FDA
Approves New Drug to Treat Niemann-Pick Disease, Type C |
| September 24, 2024 - FDA
Roundup: September 24, 2024 |
| September 20, 2024 - FDA
Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration |
| September 20, 2024 - FDA
Approves First Treatment for Niemann-Pick Disease, Type C |
| September 20, 2024 - FDA
Roundup: September 20, 2024 |
| September 17, 2024 - FDA
Roundup: September 17, 2024 |
| September 16, 2024 - FDA
Issues Draft Guidance on Conducting Multiregional Clinical Trials
in Oncology |
| September 13, 2024 - FDA
Roundup: September 13, 2024 |
| September 12, 2024 - FDA
Authorizes First Over-the-Counter Hearing Aid Software |
| September 11, 2024 - FDA
Issues Warning Letters to Two Chinese Firms Regarding Data Quality
and Integrity Concerns, Violative Lab Practices |
| September 10, 2024 - FDA
Roundup: September 10, 2024 |
| September 6, 2024 - FDA
Roundup: September 6, 2024 |
| September 5, 2024 - Youth
E-Cigarette Use Drops to Lowest Level in a Decade |
| August 30, 2024 - FDA
Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against
Currently Circulating Variants |
| August 30, 2024 - FDA
Roundup: August 30, 2024 |
| August 29, 2024 - FDA
Issues Final Rule Increasing the Minimum Age for Certain Restrictions
on Tobacco Sales |
| August 27, 2024 - FDA
Roundup: August 27, 2024 |
| August 26, 2024 - FDA
Clears First Device to Enable Automated Insulin Dosing for Individuals
with Type 2 Diabetes |
| August 23, 2024 - FDA
Roundup: August 23, 2024 |
| August 22, 2024 - FDA
Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect
Against Currently Circulating Variants |
| August 20, 2024 - FDA
Roundup: August 20, 2024 |
| August 16, 2024 - FDA
Marketing Authorization Enables Increased Access to First Step of
Syphilis Diagnosis |
| August 16, 2024 - FDA
Roundup: August 16, 2024 |
| August 15, 2024 - FDA
Issues Warning Letter to Austrofood and Continues Robust Activities
to Ensure Safety of Cinnamon Products Sold in U.S. |
| August 15, 2024 - FDA
Announces Milestone in Sodium Reduction Efforts, Issues Draft Guidance
with Lower Target Levels for Certain Foods |
| August 13, 2024 - FDA
Roundup: August 13, 2024 |
| August 9, 2024 - FDA
Approves First Nasal Spray for Treatment of Anaphylaxis |
| August 9, 2024 - FDA
Roundup: August 9, 2024 |
| August 7, 2024 - FDA
Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid
Overdose |
| August 6, 2024 - FDA
Roundup: August 6, 2024 |
| August 2, 2024 - FDA
Approves First Gene Therapy to Treat Adults with Metastatic Synovial
Sarcoma |
| August 2, 2024 - FDA
Roundup: August 2, 2024 |
| July 30, 2024 - FDA
Roundup: July 30, 2024 |
| July 26, 2024 - FDA
Roundup: July 26, 2024 |
| July 23, 2024 - FDA
Roundup: July 23, 2024 |
| July 16, 2024 - FDA,
FTC Continue Joint Effort to Protect Consumers Against Companies Illegally
Selling Copycat Delta-8 THC Food Products |
| July 16, 2024 - FDA
Roundup: July 16, 2024 |
| July 12, 2024 - FDA
Roundup: July 12, 2024 |
| July 8, 2024 - FDA
Updates Guidance to Further Empower Companies to Address the Spread
of Misinformation |
| July 5, 2024 - FDA
Roundup: July 5, 2024 |
| July 2, 2024 - FDA
Roundup: July 2, 2024 |
| June 28, 2024 - FDA
Roundup: June 28, 2024 |
| June 27, 2024 - FDA
Permits Marketing of First Point-of-Care Hepatitis C RNA Test |
| June 26, 2024 - FDA
Guidance Provides New Details on Diversity Action Plans Required for
Certain Clinical Studies |
| June 25, 2024 - FDA
Roundup: June 25, 2024 |
| June 21, 2024 - FDA
Roundup: June 21, 2024 |
| June 21, 2024 - FDA
Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products
After Extensive Scientific Review |
| June 20, 2024 - FDA
Expands Approval of Gene Therapy for Patients with Duchenne Muscular
Dystrophy |
| June 18, 2024 - FDA
Roundup: June 18, 2024 |
| June 14, 2024 - FDA
Roundup: June 14, 2024 |
| June 12, 2024 - Biden-Harris
Administration Announces National Strategy to Reduce Food Loss and
Waste and Recycle Organics |
| June 11, 2024 - FDA
Roundup: June 11, 2024 |
| June 10, 2024 - Justice
Department and FDA Announce Federal Multi-Agency Task Force to Curb
the Distribution and Sale of Illegal E-Cigarettes |
| June 7, 2024 - FDA
Roundup: June 7, 2024 |
| June 4, 2024 - FDA
Roundup: June 4, 2024 |
| May 31, 2024 - FDA
Roundup: May 31, 2024 |
| May 30, 2024 - FDA,
USDA, EPA enhance efforts to reduce food loss and waste, welcome USAID
to interagency collaborative |
| May 30, 2024 - FDA’s
Reorganization Approved for Establishing Unified Human Foods Program,
New Model for Field Operations and Other Modernization Efforts |
| May 28, 2024 - FDA
Approves First Interchangeable Biosimilar for Two Rare Diseases |
| May 28, 2024 - FDA
Roundup: May 28, 2024 |
| May 24, 2024 - FDA
Roundup: May 24, 2024 |
| May 21, 2024 - FDA
Roundup: May 21, 2024 |
| May 17, 2024 - FDA
Roundup: May 17, 2024 |
| May 14, 2024 - FDA
Roundup: May 14, 2024 |
| May 10, 2024 - FDA
Roundup: May 10, 2024 |
| May 9, 2024 - FDA
Issues Final Guidance to Clarify “Remanufacturing” of Devices
that Need Maintenance or Repair |
| May 8, 2024 - EPA,
FDA, and USDA Issue Joint Regulatory Plan for Biotechnology |
| May 7, 2024 - FDA
Roundup: May 7, 2024 |
| May 3, 2024 - FDA
Roundup: May 3, 2024 |
| May 1, 2024 - FDA
Clarifies Approach to Genomic Alterations in Animals |
| April 30, 2024 - FDA
Roundup: April 30, 2024 |
| April 29, 2024 - FDA
Takes Action Aimed at Helping to Ensure the Safety and Effectiveness
of Laboratory Developed Tests |
| April 29, 2024 - FDA
to Hold Listening Session as Part of Broader Work to Optimize Use
of, and Processes for, Advisory Committees |
| April 26, 2024 - FDA
Roundup: April 26, 2024 |
| April 24, 2024 - FDA
Approves New Treatment for Uncomplicated Urinary Tract Infections |
| April 23, 2024 - FDA
Roundup: April 23, 2024 |
| April 19, 2024 - FDA
Roundup: April 19, 2024 |
| April 16, 2024 - FDA
Roundup: April 16, 2024 |
| April 12, 2024 - FDA
Roundup: April 12, 2024 |
| April 9, 2024 - Federal
Court Enters Consent Decree Against Philips Respironics Following
Recall of Certain Sleep Therapy Machines |
| April 9, 2024 - FDA
Roundup: April 9, 2024 |
| April 5, 2024 - FDA
Roundup: April 5, 2024 |
| April 3, 2024 - FDA
Approves New Antibiotic for Three Different Uses |
| April 2, 2024 - FDA
Roundup: April 2, 2024 |
| March 29, 2024 - FDA
Roundup: March 29, 2024 |
| March 26, 2024 - FDA
Warns Consumers to Avoid Certain Topical Pain Relief Products Due
to Potential for Dangerous Health Effects |
| March 26, 2024 - FDA
Roundup: March 26, 2024 |
| March 22, 2024 - FDA
Roundup: March 22, 2024 |
| March 21, 2024 - FDA
Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy |
| March 19, 2024 - FDA
Roundup: March 19, 2024 |
| March 18, 2024 - FDA
Approves First Gene Therapy for Children with Metachromatic Leukodystrophy |
|
March 15, 2024 - FDA
Roundup: March 15, 2024
|
| March 14, 2024 - FDA
Approves First Treatment for Patients with Liver Scarring Due to Fatty
Liver Disease |
| March 12, 2024 - FDA
Roundup: March 12, 2024 |
| March 11, 2024 - FDA
Seeks $7.2 Billion to Enhance Food Safety and Nutrition, Advance Medical
Product Safety, and Strengthen Public Health |
| March 8, 2024 - FDA
Approves First Treatment to Reduce Risk of Serious Heart Problems
Specifically in Adults with Obesity or Overweight |
| March 8, 2024 - FDA
Roundup: March 8, 2024 |
| March 6, 2024 - FDA
Takes Steps to Ensure Safety of Cinnamon Products Sold in the US |
| March 5, 2024 - FDA
Roundup: March 5, 2024 |
| March 5, 2024 - FDA
Clears First Over-the-Counter Continuous Glucose Monitor |
| March 1, 2024 - FDA
Roundup: March 1, 2024 |
| February 28, 2024 - FDA,
Industry Actions End Sales of PFAS Used in US Food Packaging |
| February 27, 2024 - FDA
Roundup: February 27, 2024 |
| February 23, 2024 - FDA
Roundup: February 23, 2024 |
| February 20, 2024 - FDA
Roundup: February 20, 2024 |
| February 16, 2024 - FDA
Approves First Cellular Therapy to Treat Patients with Unresectable
or Metastatic Melanoma |
| February 16, 2024 - FDA
Approves First Medication to Help Reduce Allergic Reactions to Multiple
Foods After Accidental Exposure |
| February 16, 2024 - FDA
Roundup: February 16, 2024 |
| February 14, 2024 - FDA
Approves First Medication to Treat Severe Frostbite |
| February 13, 2024 - FDA
Roundup: February 13, 2024 |
| February 9, 2024 - FDA
Roundup: February 9, 2024 |
| February 6, 2024 - FDA
Roundup: February 6, 2024 |
| February 2, 2024 - FDA
Roundup: February 2, 2024 |
| January 30, 2024 - FDA
Roundup: January 30, 2024 |
| January 26, 2024 - FDA
Roundup: January 26, 2024 |
| January 23, 2024 - FDA
Roundup: January 23, 2024 |
| January 19, 2024 - FDA
Roundup: January 19, 2024 |
| January 16, 2024 - FDA
Roundup: January 16, 2024 |
| January 12, 2024 - FDA
Roundup: January 12, 2024 |
| January 9, 2024 - FDA
Roundup: January 9, 2024 |
| January 8, 2024 - FDA
Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical
Device Sterilization |
| January 5, 2024 - FDA
Authorizes Florida’s Drug Importation Program |
| January 5, 2024 - FDA
Roundup: January 5, 2024 |
| January 2, 2024 - FDA
Roundup: January 2, 2024 |
For the most up to date FDA headlines, see the FDA
Medical Device News page.
| November 15, 2024
Consumer Information: GORE
EXCLUDER Conformable AAA Endoprostheses (EXCC) - P200030/S014
(W.L. Gore & Associates, Inc.)
Consumer Information: TruSight
Oncology Comprehensive - P230011
(Illumina, Inc)
Consumer Information: Simplera
system - P160007/S047
(Medtronic MiniMed, Inc.)
Consumer
Information: UNIPURE SF6 Ophthalmic Gas UNIFEYE Gas Delivery System
and UNIPURE SF6 Ophthalmic Gas UNIPEXY Gas Delivery System -
P230012
(Alcon Research, LLC)
Class
I Recall: Endoscopic Vessel Harvesting System Recall: Getinge and
Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic
Vessel
Safety
and Availability Concerns with VasoView HemoPro Endoscopic Vessel
Harvesting Systems - Letter to Health Care Providers
Medical
Device Shortages List (Updated)
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A - November 20, 2024
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
|
|
November 14, 2024
Blood
Glucose Monitoring Devices (Updated)
De Novo Decision Summaries (Updated):
- DEN230092
- Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack
& Sample Prep Kit
- DEN230011
- OcuCool
- DEN240016
- Xpert HCV; GeneXpert Xpress System
- DEN220030
- RemeOs™ Screw LAG Solid
- DEN240007
- BioHealx Anal Fistula Device
De Novo Classification Order:
- DEN230082
- Stone Clear
- DEN230083
- Valeda Light Delivery System
- DEN230084
- Dexter L6 Surgical System
|
|
November 12, 2024
Updated Emergency Use Authorization
- ORAcollect·RNA
OR-100 and ORAcollect·RNA ORE-100 saliva collection devices
(DNA Genotek Inc.)
|
| November 8, 2024
Reclassification
(Updated)
Evaluation
of Airborne Chemicals from Neonatal Incubators - Letter to Health
Care Providers (Updated)
|
|
November 7, 2024
Breakthrough
Devices Program (Updated)
Presentation
and Transcript added to Medical Device Sterilization Town Hall:
Sterilization Short Topics and Open Q&A - October 30, 2024
Alternative
Standards (MQSA): #25: Issuing a Report with the Assessment “Incomplete:
Need additional imaging evaluation” in Follow-Up to an Initial
Report with the Assessment “Incomplete: Need prior mammograms
for comparison.”
|
|
November 6, 2024
Updated Emergency Use Authorization
- cobas
MPXV for use on the cobas 6800/8800 Systems (cobas MPXV) (Roche
Molecular Systems, Inc.)
CDRH
– A Great Place for Public Health Service Officers to Work
|
|
November 5, 2024
Materials
for November 7, 2024 General and Plastic Surgery Devices Panel of
the Medical Devices Advisory Committee Meeting
|
|
November 4, 2024
De Novo Decision Summaries (Updated):
- DEN220024
- ScanNav Anatomy Peripheral Nerve Block
- DEN210037
- SoClean 3+ Bacterial Reduction Device
- DEN230046
- PGDx elio™ plasma focus Dx
- DEN230067
- Germitee Chronos®
- DEN230069
- Mi-CHORD System
- DEN230090
- First To Know Syphilis Test
MedSun
Newsletter - November 2024
Explore
Life at CDRH (Updated)
MQSA
National Statistics (Updates)
|
| November 1, 2024
Class
I Recall: IPV Therapy Device Recall: Percussionaire Removes Certain
Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure
|
| October 31, 2024
Class
I Recall: Incubator/Warmer Correction: GE Healthcare Updates Use
Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation
due to Risk of Heater Door Falling and Causing Infant Injury
|
|
October 29, 2024
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Webinar
– FDA’s Total Product Life Cycle Approach to In Vitro
Diagnostic Products (IVDs), October 24, 2024
- Presentation
- Transcript
Update:
Use of GE HealthCare EVair and EVair 03 Compressors - Letter to
Health Care Providers
Class
I Recall: Air Compressor Device Correction: GE HealthCare Provides
Updates to EVair Compressors Due to Final Formaldehyde Testing Results
CDRH
Learn (Updated Presentations)
- How
to Complete Form FDA 3602: MDUFA Small Business Qualification and
Certification for a Business Headquartered in the United States
- How
to Complete Form FDA 3602A: MDUFA Foreign Small Business Certification
Request for a Business Headquartered Outside the United States
|
|
October 28, 2024
Cybersecurity
(Updated)
De Novo Decision Summaries (Updated):
- DEN230023
- Rho
- DEN230034
- X100 with Full Field Bone Marrow Aspirate (BMA) Application, X100HT
with Full Field Bone Marrow Aspirate (BMA) Application
- DEN230045
- Sonu
- DEN230055
- FSYX™ Ocular Pressure Adjusting Pump System
Meeting
materials for October 30, 2024 Patient Engagement Advisory Committee
Meeting
In
Vitro Diagnostics (IVD) Roundtable – Fall Meeting
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A
- Printable
Slides
|
| October 25, 2024
Class I Recall:
- Tracheostomy
Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc
Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
- Assistive
Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic
Arm due to Fire Hazard and Burn Risk
Update:
Do Not Use BioZorb Marker Implantable Radiographic Marker Devices:
FDA Safety Communication
|
|
October 24, 2024
Revised Emergency Use Authorizations
- OHC
COVID-19/Flu Antigen Test Pro - OSANG LLC
- QuickFinder
COVID-19/Flu Antigen Self Test - OSANG LLC
Updated Emergency Use Authorizations
- Lucira
by Pfizer COVID-19 & Flu Test - Pfizer Inc.
- Flowflex
Plus COVID-19 and Flu A/B Home Test - ACON Laboratories, Inc.
Webinar
– FDA’s Total Product Life Cycle Approach to In Vitro
Diagnostic Products (IVDs), October 24, 2024
- Printable
Slides
Class
I Recall: Ventilator Correction: Baxter Healthcare Updates Use Instructions
for Life2000 Ventilation System Due to Risk of No Low Gas Pressure
Alarm
|
|
October 23, 2024
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A - October 30, 2024
|
|
October 22, 2024
IDE
Application (Updated)
|
|
October 21, 2024
De Novo Classification Order:
- DEN230076
- Omron Blood Pressure Monitor with AFib Detection Feature
- DEN230078
- Versius Surgical System
- DEN230087
- AMStent® Tracheobronichial Covered Stent System
DeNovo Decision Summaries (Updated):
- DEN220009
- VerTouch Spinal Imaging Device
- DEN220066
- BrainSee
- DEN230006
- esolution® Esophageal Retractor
- DEN230011
- OcuCool
- DEN230032
- Symani Surgical System
- DEN230064
- BraidE Embolization Assist Device
- DEN240017
- ShortCut
Reclassification
(Updated)
Federal
Register: Chemical Analysis for Biocompatibility Assessment of Medical
Devices
|
| October 18, 2024
Total
Product Life Cycle Advisory Program (TAP) (Updated)
Class
I Recall: Vascular Embolization Device Correction: Boston Scientific
Updates Use Instructions for Obsidio Conformable Embolic for Increased
Ischemia Risk When Used for GI Bleeding
Webinar
- Draft Guidance: Incorporating Voluntary Patient Preference Information
over the Total Product Life Cycle - 10/15/2024 (Updated)
- Presentation
-
Printable Slides
- Transcript
|
|
October 17, 2024
Class
I Recall: Insulin Pump Recall: Medtronic Notifies Users of MiniMed
600 and 700 Series Pumps of Risk of Shorter than Expected Battery
Life
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A
- Presentation
- Printable
Slides
- Transcript
Federal
Register: Accreditation Scheme for Conformity Assessment Program
|
|
October 16, 2024
Ventilators
and Ventilator Accessories EUAs (Updated)
CDRH
Petitions (Updated)
|
|
October 15, 2024
Influenza
Diagnostic Tests (Updated)
Electronic
Medical Devices, X-ray Imaging and Radiation Therapy: What to Know
and How to Prevent Damage
Device
Trial Participation Snapshots
De Novo Classification Order: DEN240029
- Healgen Rapid Check COVID-19/flu A&B Antigen Test
De Novo Decision Summaries (Updated):
- DEN200076
- ORi
- DEN210058
- ELEOSx™ Limb Salvage System
- DEN220015
- Orthobond Mariner Pedicle Screw System
- DEN220073
- Revi System
- DEN230008
- DermaSensor
- DEN230035
- DentalMonitoring
- DEN230043
- Notal Vision Home Optical Coherence Tomography (OCT) System
- DEN230081
- Hearing Aid Feature
- DEN240013
- MagDI System
|
| October 11, 2024
Revoked Emergency Use Authorizations
- Cue
COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health
Inc.)
- Cue
COVID-19 Test (Cue Health Inc.)
Endosseous
Dental Implants and Endosseous Dental Implant Abutments - Performance
Criteria for Safety and Performance Based Pathway - Guidance for
Industry and Food and Drug Administration Staff
Safety
and Performance Based Pathway (Updated)
Class
I Recall: Infusion Pump Recall: Zyno Medical Removes Certain Z-800,
Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line
Software Defect That May Allow Larger than Expected Air Bubbles
to Enter Patients
|
|
October 10, 2024
CDRH
Proposed Guidance Development (Updated)
CDRH
Proposed Guidances for Fiscal Year 2025 (FY2025)
|
|
October 8, 2024
Consumer Information: SHIELD
- P230009
(Guardant Health, Inc.)
Resources
and Interactions with FDA: Laboratory Developed Tests FAQs (Updated)
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A - October 9, 2024
- Printable
Slides
|
|
October 7, 2024
Consumer Information: UNIPURE
C3F8 Ophthalmic Gas, UNIFEYE Gas Delivery System, UNIPLEX Gas Delivery
System - P220030
(Alcon Research, LLC)
Consumer Information: MYNX
Control™ Venous Closure Device (VCD) - P040044/S097
(Cordis US Corporation)
De Novo Decision Summaries (Updated):
- DEN230015
- Osteoboost Belt
- DEN230024
- Technozym ADAMS13 Activity
De Novo Classification Orders:
- DEN230019
- AXIOS Stent and ElectroUcautery-Enhanced Delivery System
- DEN230011
- OcuCool
- DEN240017
- ShortCut
CDRH's
Experiential Learning Program (ELP) (Updated)
Experiential
Learning Program (ELP) Areas of Interest (Updated)
Class
I Recall: Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece
Resuscitators due to Risk of Inline Controller Detachment that May
Impact Ventilation
|
|
October 4, 2024
Revoked Emergency Use Authorization
- B.
Braun Space and Outlook Pumps (B.Braun Medical, Inc.)
Total
Product Life Cycle Advisory Program (TAP) (Updated)
|
|
October 3, 2024
Revised Emergency Use Authorizations
- Tyfast
Flu A/B & COVID-19 Multiplex Rapid Test (CorDx, Inc.)
- TyFast
Flu A/B & COVID-19 At Home Multiplex Rapid Test (CorDx, Inc.)
Updated Emergency Use Authorization
- COVID-19/Flu
A&B Ag Combo Rapid Test Cassette (Swab) (Healgen Scientific,
LLC)
Send
and Track Medical Device Premarket Submissions Online: CDRH Portal
(Updated)
CDRH
Learn: MDUFA Small Business Program (Updated)
MedSun
Newsletter - October 2024
|
|
October 2, 2024
MQSA
National Statistics (Updated)
Class
I Recall: IPV Therapy Device Correction: Sentec/Percussionaire Updates
Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental
Misuse of Expiratory Port Plug
Medical
Device Shortages List (Updated)
|
|
October 1, 2024
Class
I Recall: Infusion Pump Software Correction: Fresenius Kabi USA,
LLC, Issues Correction for Ivenix Infusion System Large Volume Pump
(LVP) Software due to Multiple Anomalies that May Cause Delay or
Underdosage of Therapy
Class
I Recall: Ventilator Software Correction: Philips Respironics Issues
Mandatory Software Correction and Updates Use Instructions for Trilogy
Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues
that May Impact Ventilation
Webinar
- Registration & Listing Requirements for In Vitro Diagnostic
Products (IVDs), Including Laboratory Developed Tests (LDTs) - 12/03/2024
Total
Product Life Cycle Advisory Program (TAP) (Updated)
|
| September 30, 2024
Safety
and Performance Based Pathway (Updated)
Class
I Recall: Ventilator Correction: Smiths Medical Issues Correction
for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal
Volume Knob Movement
De Novo Classification Order: DEN230067
- Chronos®
De Novo Decision Summaries (Updated)
- DEN220040
- Fibresolve
- DEN220026
- VasQ
- DEN230020
- BioTraceIO Lite
- DEN210056
- ProciseDx Inc.
- DEN230050
- Body Temperature Software (BTS)
- DEN220090
- EasySep™ Human Bone Marrow CD138 Positive Selection Kit
- DEN230012
- Ruthless Spine RJB
- DEN220023
- Procise ADL
|
| September 27, 2024
Medical
Device Sterilization Town Hall: Sterilization Short Topics and Open
Q&A - October 9, 2024
Electronic
Product Radiation Control Program: Industry Guidance (Updated)
Clarification
of Radiation Control Regulations For Manufacturers of Diagnostic
X-Ray Equipment: Guidance for Industry and Food and Drug Administration
Staff
Air
Powered Dental Handpieces and Air Motors - Performance Criteria
for Safety and Performance Based Pathway - Guidance for Industry
and Food and Drug Administration Staff
Dental
Cements - Performance Criteria for Safety and Performance Based
Pathway - Guidance for Industry and Food and Drug Administration
Staff
Dental
Ceramics - Performance Criteria for Safety and Performance Based
Pathway - Guidance for Industry and Food and Drug Administration
Staff
Dental
Impression Materials - Performance Criteria for Safety and Performance
Based Pathway - Guidance for Industry and Food and Drug Administration
Staff
Specific
Test Categories or Technologies: Laboratory Developed Tests FAQs
(Updated)
Federal
Register: Safety and Performance Based Pathway Device-Specific Guidances
Federal
Register: Radiation Control Regulations for Manufacturers of Diagnostic
X-Ray Equipment
Safety
and Performance Based Pathway (Updated)
Webinar:
Labeling Requirements for In Vitro Diagnostic Products (IVD), Including
LDTs, Under 21 CFR 809.10(b), September 24, 2024
- Presentation
- Transcript
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
At-Home
COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
|
|
September 26, 2024
FDA
Digital Health and Artificial Intelligence Glossary - Educational
Resource
|
|
September 24, 2024
Class
I Recall: Compounding Device Inlet Correction: Baxter Healthcare
Corporation Updates Use Instructions for Exactamix Automated Compounding
Device Inlets due to Risk for Particulate Matter in Device Components
Medical
Acoustics Program: Research on Medical Acoustic Devices (Updated)
CDRH
Patient Engagement Advisory Committee (Updated)
Federal
Register: Microbiology Devices: Reclassification of Antigen, Antibody,
and Nucleic Acid-Based Hepatitis B Virus Assay Devices
|
|
September 23, 2024
Consumer Information: Altius
Direct Electrical Nerve Stimulation System - P230020
(Neuros Medical, Inc.)
De Novo Decision Summaries Updated:
- DEN230019
- AXIOS Stent and Electrocautery-Enhanced Delivery System
- DEN230002
- DuraGraft Vascular Conduit Solution
- DEN220087
- Edison System
- DEN230021
- ensoETM™
- DEN220078
- Eroxon
|
| September 20, 2024
Revised Emergency Use Authorizations
- OSOM
Flu SARS-CoV-2 Combo Test (SEKISUI Diagnostics, LLC)
- OSOM
Flu SARS-CoV-2 Combo Home Test (SEKISUI Diagnostics, LLC)
- OSOM
Flu SARS-CoV-2 Combo Home Test (SEKISUI Diagnostics, LLC)
Consumer Information: Minima
Stent System - P240003
(Renata Medical)
Reclassification
(Updated)
Class
I Recall: Ventilator Recall: Smiths Medical Removes ParaPAC Plus
Ventilators due to Loosened or Detached Patient Outlet Connector
Accreditation
Scheme for Conformity Assessment (ASCA) (Updated)
The
Accreditation Scheme for Conformity Assessment (ASCA) 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) 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) Program:
Guidance for Industry, Accreditation Bodies, Testing Laboratories,
and Food and Drug Administration Staff
Federal
Register: Guidance - Accreditation Scheme for Conformity Assessment
Program
Federal
Register: Microbiology Devices - Reclassification of Cytomegalovirus
Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant
Patient Management
Collaborative
Communities with CDRH Participation (Updated)
|
|
September 19, 2024
Chemical
Analysis for Biocompatibility Assessment of Medical Devices - Draft
Guidance for Industry and Food and Drug Administration Staff
Biocompatibility
Assessment Resource Center (Updated)
Federal
Register: Guidance: Chemical Analysis for Biocompatibility Assessment
of Medical Devices
|
|
September 18, 2024
Class
I Recall: Tracheostomy Tube Recall: Smiths Medical Removes Certain
Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes due to Manufacturing
Defect that May Cause Tracheostomy Displacement or Decannulation
Federal
Register: Agency Information Collection Activities; Submission for
Office of Management and Budget Review; Comment Request; Medical
Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User
Fee Cover Sheet, Form 3601a
|
|
September 17, 2024
November
20-21, 2024: Digital Health Advisory Committee Meeting Notice
Zimmer
Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone
Fracture - FDA Safety Communication
Class
I Recall: Infusion Pump Correction: B. Braun Medical Inc. Issues
Correction for lnfusomat Space Infusion System/Large Volume Pump,
in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat
Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Faulty
Occlusion Alarm
De Novo Reclassification Order - DEN230067
- Chronos®
De Novo Decision Summaries Updated:
- DEN210055
- N-SWEAT Patch
- DEN220048
- Neoasis
- DEN220033
- MISHA(TM) Knee System
- DEN200029
- Parallel
|
|
September 16, 2024
Updated Emergency Use Authorizations
- OSOM
Flu SARS-CoV-2 Combo Test (SEKISUI Diagnostics, LLC)
- STANDARD
Q COVID-19 Ag Test 2.0 (SD Biosensor, Inc.)
- iHealth
COVID-19/Flu A&B Rapid Test (iHealth Labs, Inc.)
- iHealth
COVID-19/Flu A&B Rapid Test Pro (iHealth Labs, Inc.)
Class
I Recall: Infusion Pump Administration Set Recall: Fresenius Kabi
USA Removes Certain Ivenix Large Volume Pump Primary Administration
Sets
Federal
Register: Digital Health Advisory Committee; Total Product Lifecycle
Considerations for Generative Artificial Intelligence-Enabled Medical
Devices
Federal
Register: Immunology and Microbiology Devices; Classification of
the Quantitative Viral Nucleic Acid Test for Transplant Patient
Management
|
| September 13, 2024
November
7, 2024: General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee Meeting Notice
Webinar
- The Voluntary Improvement Program: How to Enroll, Opportunities,
and Best Practices - October 8, 2024
Federal
Register: Medical Devices: Clinical Chemistry and Clinical Toxicology
Devices; Classification of the Clozapine Test System
Federal
Register: Medical Devices: Immunology and Microbiology Devices;
Classification of the Device to Detect or Measure Nucleic Acid from
Viruses Associated with Head and Neck Cancers
Federal
Register: Medical Devices: Therapeutic Devices; Classification of
the Pediatric Continuous Renal Replacement Therapy System
|
|
September 12, 2024
Federal
Register: General and Plastic Surgery Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting; Establishment of
Public Docket; Request for Comments--ProSense Cryoablation System
|
|
September 10, 2024
Appeal
Options Available to Mammography Facilities Concerning Adverse Accreditation
Decisions, Suspension / Revocation of Certificates, or Patient and
Referring Provider Notification Orders - Guidance for Mammography
Facilities and Food and Drug Administration Staff
Related
Recalls - Plastic Syringes Made in China for Potential Device Failures
(Updated)
Mammography
Quality Standards Act (MQSA) and MQSA Program (Updated)
Important
Information: Final Rule to Amend the Mammography Quality Standards
Act (MQSA) (Updated)
Frequently
Asked Questions About MQSA (Updated)
Facility
Accreditation and Certification (Updated)
The
Annual MQSA Inspection: What Facilities Can Do to Help (Updated)
Mammography
Information for Patients (Updated)
Federal
Register: Medical Devices: Immunology and Microbiology Devices;
Classification of the Whole Exome Sequencing Constituent Device
|
|
September 9, 2024
MedSun Newsletter - September 2024
De Novo(s) Decision Summaries Updated:
- DEN220083
- Stanza
- DEN220059
- NTX100 Tonic Motor Activation (NTX100 ToMAc) System
- DEN220027
- B-R-A-H-M-S sFlt-1/PIGF KRYPTOR Test System
- DEN220058
- BT-001
- DEN220041
- TRISTEL DIO ULT
- DEN230036
- Sepsis ImmunoScore
- DEN200052
- KidneyIntelX.dkd
De Novo Reclassification Order - DEN230090
First To Know Syphilis Test (NOWDiagnostics)
|
|
September 6, 2024
Insulin
Pumps: Tips for Using Your Insulin Pump at Home
Infusion
Pumps: Tips for Using Your Pump at Home
GUDID
Data Trends (Updated)
Augmented
Reality and Virtual Reality in Medical Devices (Updated)
Federal
Register: Gastroenterology-Urology Devices; Classification of the
Endoscopic Pancreatic Debridement Device
Federal
Register: Clinical Chemistry and Clinical Toxicology Devices; Classification
of the Blood Collection Device for Cell-free Nucleic Acids
|
|
September 5, 2024
Incorporating
Voluntary Patient Preference Information over the Total Product
Life Cycle - Draft Guidance for Industry, Food and Drug Administration
Staff, and Other Interested Parties
Webinar
- Draft Guidance: Incorporating Voluntary Patient Preference Information
over the Total Product Life Cycle - October 15, 2024
Webinar
- FDA’s Total Product Life Cycle Approach to In Vitro Diagnostic
Products (IVDs) - October 24, 2024
Laboratory
Developed Tests (Updated)
Patient
Preference Information (PPI) in Medical Device Decision Making (Updated)
Class I Recalls:
- Laryngoscope
Recall: Medtronic Removes Certain McGrath MAC Video Laryngoscopes,
Updates Use Instructions for Others due to Increased Risk for Battery
Overheat and Explosion
- Continuous
Glucose Monitoring (CGM) Sensor Recall: Abbott Diabetes Care Inc
Issues Recall for Certain FreeStyle Libre 3 Sensors due to Risk
for Inaccurate High Glucose Readings
- Ventilator
Correction: Breas Medical Updates Use Instructions for Vivo 45 LS
due to Potential Elevated Formaldehyde Levels in Newly Manufactured
Ventilators
Federal
Register: Incorporating Voluntary Patient Preference Information
over the Total Product Life Cycle
Federal
Register: Gastroenterology-Urology Devices; Classification of the
Hemodialyzer With Expanded Solute Removal Profile
|
|
September 4, 2024
Influenza
Diagnostic Tests (Updated)
CDRH's
Experiential Learning Program (ELP) (Updated)
Experiential
Learning Program (ELP) Areas of Interest (Updated)
Emergency
Situations (Medical Devices) (Updated)
CLIA
Waiver by Application Decision Summaries (Updated)
Federal
Register: Cardiovascular Devices; Classification of the Adjunctive
Open Loop Fluid Therapy Recommender
Federal
Register: Dental Devices; Classification of the Radiofrequency Toothbrush
Federal
Register: Hematology and Pathology Devices; Classification of the
Heparin and Direct Oral Factor Xa Inhibitor Drug Test System
Federal
Register: Ophthalmic Devices; Classification of the Hydrophilic
Re-Coating Solution
|
|
September 3, 2024
CDRH
Learn: Introduction to Medical Device Recalls
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
MQSA
National Statistics (Updated)
|
| August 30, 2024
CDRH
Learn: Overview of Quality Management System Regulation (New module)
CDRH
Learn: Navigating the Quality Management System Regulation (New
module)
Federal
Register: Dental Devices; Classification of the Neuromuscular Tongue
Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep
Apnea
Federal
Register: Neurological Devices; Classification of the Digital Therapy
Device for Attention Deficit Hyperactivity Disorder
Federal
Register: Orthopedic Devices; Classification of the Intervertebral
Body Graft Containment Device
Federal
Register: Physical Medicine Devices; Classification of the External
Compression Device for Internal Jugular Vein Compression
Medical
Device Sterilization Town Hall: Sterility Master Files and Effective
Use in Premarket Submissions, September 11, 2024
Sterilization
for Medical Devices (Updated)
|
|
August 28, 2024
October
30, 2024: Patient Engagement Advisory Committee Meeting
Voluntary
Malfunction Summary Reporting (VMSR) Program for Manufacturers -
Guidance for Industry and Food and Drug Administration Staff
Voluntary
Malfunction Summary Reporting Program
CDRH
Patient Engagement Advisory Committee (Updated)
De Novo Decision Summaries added:
- DEN230008
- DEN210035
- DEN190038
- DEN220082
- DEN210039
- DEN190035
- DEN230007
- DEN220063
- DEN220065
- DEN200011
- DEN220044
- DEN210022
- DEN200067
- DEN210027
- DEN200062
Federal
Register: Hearings, Meetings, Proceedings, etc.: Patient Engagement
Advisory Committee; Patient-Centered Informed Consent in Clinical
Study
Federal
Register: Medical Devices and Device-led Combination Products: Voluntary
Malfunction Summary Reporting for Manufacturers
Federal
Register: Guidance: Voluntary Malfunction Summary Reporting Program
for Manufacturers
|
|
August 27, 2024
Consumer Information: ColoSense
– P230001
Presentation
and Transcript added for In Vitro Diagnostic Products (IVDs) - MDR
Requirements, Correction and Removal Reporting Requirements, and
Quality System Complaint Requirements - 08/22/2024
CDRH
Management Directory by Organization (Updated)
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
Patient
Engagement Advisory Committee; Patient-Centered Informed Consent
in Clinical Study
|
|
August 26, 2024
eMDR
System Enhancements (Updated)
Coding
Resources for Medical Device Reports (Updated)
Health
Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files
(Updated)
MDR
Data Files (Updated)
Voluntary
Recall of SoClean Equipment Intended for Use with CPAP Devices and
Accessories: FDA Safety Communication (Updated)
Federal
Register: Mammography Quality Standards Act and Regulation Amendments:
Small Entity Compliance Guide; Guidance for Industry and Food and
Drug Administration Staff; Availability
Federal
Register: Withdrawal of Approval and Amending of Mammography Quality
Standards Act Alternative Standards
|
|
August 23, 2024
Revoked Emergency Use Authorizations
- Procleix
SARS-CoV-2 Assay (Grifols Diagnostic Solutions Inc.)
- LumiraDx
SARS-CoV-2 RNA STAR (LumiraDx UK Ltd.)
Mammography
Quality Standards Act and Regulation Amendments: Small Entity Compliance
Guide - Guidance for Industry and Food and Drug Administration Staff
Mammography
Quality Standards Act and Program (Updated)
Federal
Register: Authorization of Emergency Use of Certain Medical Devices
During COVID-19; Availability
Federal
Register: Electronic Submission Template for Medical Device De Novo
Requests
Webinar
– Final Guidance: Remanufacturing of Medical Devices
At-Home
COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Class
I Recall: Clot Removal Device Correction: Inari Medical Updates
Use Instructions for ClotTriever XL Catheter due to Reports of Patient
Injury and Death from Device Entrapment and Pulmonary Emboli
|
|
August 22, 2024
Electronic
Submission Template for Medical Device De Novo Requests - Guidance
for Industry and Food and Drug Administration Staff
FDA
and Industry Procedures for Section 513(g) Requests for Information
under the Federal Food, Drug, and Cosmetic Act - Guidance for Industry
and Food and Drug Administration Staff
Federal
Register: Predetermined Change Control Plans for Medical Devices;
Draft Guidance for Industry and Food and Drug Administration Staff;
Availability
Class
I Recall: Chest Compression Device Recall: Defibtech, LLC, Removes
RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping
Compressions
|
|
August 21, 2024
Updated Emergency Use Authorization
- Influenza
SARS-CoV-2 (Flu SC2) Multiplex Assay (Centers for Disease Control
and Prevention (CDC))
CDRH
Petitions (Updated)
Webinar
– Draft Guidance: Predetermined Change Control Plans for Medical
Devices
510(k)
Third Party Performance Metrics and Accreditation Status (Updated)
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
Predetermined
Change Control Plans for Medical Devices - Draft Guidance for Industry
and FDA Staff
|
|
August 20, 2024
Division
of Industry and Consumer Education Educational Newsletter - August
2024External Link Disclaimer
Class
I Recall: Infusion Pump Battery Correction: ICU Medical Updates
Instructions for Use Regarding Batteries in Plum 360, A+ and A+3
Infusion System due to Diminished Battery Life that May Impact Infusion
Delivery
Acceptable
Media for Electronic Product User Manuals - Guidance for Industry
and FDA Staff
|
|
August 19, 2024
Consumer Information: BD
Onclarity HPV Assay - P160037/S017
(Becton, Dickinson and Company)
For Classification: SoClean
3+ Bacterial Reduction Device - DEN210037
(SoClean, Inc.)
|
| August 15, 2024
CDRH
FOIA: How to Get Records from CDRH (Updated)
Pediatric
and Perinatal Devices Program: Research of Pediatric and Perinatal
Devices
Federal
Register: General Hospital and Personal Use Devices; Classification
of the Intravenous Catheter Force-Activated Separation Device
Federal
Register: Immunology and Microbiology Devices; Classification of
the Device To Detect and Identify Nucleic Acid Targets Including
SARS-CoV-2 in Respiratory Specimens
Federal
Register: Immunology and Microbiology Devices; Classification of
the Device to Detect and Identify Selected Microbial Agents That
Cause Acute Febrile Illness
|
|
August 14, 2024
Webinar
- Labeling Requirements for In Vitro Diagnostic Products (IVD),
Including LDTs, Under 21 CFR 809.10(b) - September 24, 2024
|
|
August 13, 2024
Revised Emergency Use Authorization
- cobas
liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (Roche
Molecular Systems, Inc.)
New Emergency Use Authorization
- Flowflex
Plus COVID-19 and Flu A/B Home Test (ACON Laboratories, Inc.)
Consumer
Information: Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 RESILIA
Transcatheter Heart Valve System - P140031/S162
(Edwards Lifesciences, LLC)
|
|
August 12, 2024
CDRH
Petitions (Updated)
For Classification: VerTouch
Spinal Imaging Device - DEN220009
(IntuiTap Medical, Inc.)
For Classification: PGDx
elio plasma focus Dx - DEN230046
(Personal Genome Diagnostics, Inc.)
|
| August 8, 2024
Revoked Emergency Use Authorizations
- Sampinute
COVID-19 Antigen MIA (Celltrion USA, Inc.)
- Celltrion
DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
- Celltrion
DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- cobas
SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (cobas
SARS-CoV-2) (Roche Molecular Systems)
- LumiraDx
SARS-CoV-2 & Flu A/B RNA STAR Complete Assay (LumiraDx UK Ltd.)
MedSun
Newsletter - August 2024
|
|
August 7, 2024
Updated Emergency Use Authorization
- SalivaDirect
DTC Saliva Collection Kit (SalivaDirect, Inc.)
Artificial
Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
(Updated)
|
|
August 6, 2024
Class I Recalls
- Ambulatory
Infusion Pump Software Correction: Smiths Medical Issues Correction
for CADD-Solis and CADD-Solis VIP Ambulatory Infusion Pump Software
due to Multiple Issues Related to Outdated Software
-Nerve
Monitoring System Correction: Medtronic Issues Correction for NIM
Vital Nerve Monitoring System due to the Potential for False Negative
Response
|
|
August 5, 2024
Discussion
Paper: Health Equity For Medical Devices
CDRH
Strategic Priorities and Updates (Updated)
Risks
with Exactech Joint Replacement Devices with Defective Packaging
- FDA Safety Communication (Updated)
|
|
August 2, 2024
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
|
|
August 1, 2024
Reprocessing
Single-Use Medical Devices: Information for Health care Facilities
Reprocessed
Single-Use Devices: Frequently Asked Questions
MQSA
National Statistics (Updated)
Medical
Device User Fee Amendments (MDUFA) (Updated)
Device
Registration and Listing (Updated)
|
| July 31, 2024
Safe
Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes
– Letter to Health Care Providers
|
|
July 30, 2024
Federal
Register: Medical Device User Fee Rates for Fiscal Year 2025
|
| July 29, 2024
MagDI
System - DEN240013
(GT Metabolic Solution, Inc.)
Simplexa
C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa
C. auris Sample Prep Kit - DEN230092
(DiaSorin Molecular LLC)
Terragene
Bionova Photon Biological Indicator (BT225);Terragene Bionova Photon
Auto-Reader Incubator (BPH) - DEN220042
(Terragene SA)
In
situ polymerizing peripheral nerve cap - DEN230061
(Tulavi Therapeutics)
|
|
July 26, 2024
Updated Emergency Use Authorization
-
Nano-Check Influenza+COVID-19 Dual Test (Nano-Ditech Corporation)
|
|
July 25, 2024
Digital Health Blog: A
Lifecycle Management Approach toward Delivering Safe, Effective
AI-enabled Health Care
|
|
July 24, 2024
Reissued Emergency Use Authorization
- Labcorp
Monkeypox PCR Test Home Collection Kit (Labcorp)
Medical
Device Sterilization Town Hall: Short Topics and Open Q&A, August
7, 2024
Sterilization
for Medical Devices (Updated)
Federal
Register: Emergency Use Authorization: Certain Medical Devices during
COVID-19
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
|
|
July 23, 2024
New Emergency Use Authorization
- Nano-Check
Influenza+COVID-19 Dual Test (Nano-Ditech Corporation)
Consumer Information: Occlutech
ASD Occluder and Occlutech Pistol Pusher - P200032
(Occlutech Holding AG)
RefleXion
Medical Radiotherapy System - DEN220014
(RefleXion Medical Inc.)
BioXmark
- DEN220017
(Nanovi A/S)
|
| July 18, 2024
Public
Workshop –Accreditation Scheme for Conformity Assessment and
Use of Chemical Analysis to Support Biocompatibility of Medical
Devices - 11/06/2024
Standards
Newsletter from the Division of Standards and Conformity AssessmentExternal
Link Disclaimer (July 2024)
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
ASCA-Accredited
Testing Laboratories (Updated
|
|
July 17, 2024
Updated Emergency Use Authorization
- CDC
Novel Coronavirus 2012 Real-time RT-PCR Assay (CDC)
|
|
July 16, 2024
CDRH
Petitions (Updated)
Continuous
Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions
for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or
Loss of Therapy (Updated)
|
|
July 15, 2024
CDRH
Statement: CDRH Announces Reorganization of Several Offices to Increase
Organizational Agility and Advance Public Health Mission
Class I Recall:
- Ventilator
Recall: Baxter Removes Life2000 Ventilator Due to Potential Failure
of Battery Charging Dongle
- Eye
Injection Kit Recall: Bausch + Lomb/Synergetics Inc. Removes Certain
I-Pack Injection Kits Due to Potential Non-Sterility
|
|
July 11, 2024
Updated Emergency Use Authorizations
- Genabio
COVID-19 Rapid Self-Test Kit (Genabio Diagnostics, Inc.)
-
MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical,
Inc.)
Dental
Composite Resin Devices - Premarket Notification (510(k)) Submissions
- Draft Guidance for Industry and FDA Staff
Dental
Curing Lights - Premarket Notification (510(k)) Submissions - Draft
Guidance for Industry and FDA Staff
Class
I Recall: Ventilator Software Correction: Hamilton Medical Issues
Correction for HAMILTON-C6 Medical Ventilators to Address Risk of
Failed Ventilation Restart
UGA/FDA
11th Annual Medical Device Regulations Conference - August 21, 2024
Current
Career Opportunities at CDRH (Updated)
Federal
Register: Clinical Considerations for Studies of Devices Intended
to Treat Opioid Use Disorder
Federal
Register: Dental Composite Resin Devices and Dental Curing Lights-Premarket
Notification (510(k)) Submissions Guidances
|
|
July 10, 2024
Clinical
Considerations for Studies of Devices Intended to Treat Opioid Use
Disorder - Guidance for Industry and FDA Staff
Disruptions
in Availability of BD BACTEC Blood Culture Media Bottles - Letter
to Health Care Providers
Medical
Device Shortages List (Updated)
Webinar
- In Vitro Diagnostic Products (IVDs) - MDR Requirements, Correction
and Removal Reporting Requirements, and Quality System Complaint
Requirements - August 22, 2024
Continuous
Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions
for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or
Loss of Therapy (Updated)
|
|
July 9, 2024
Do
Not Use Medtronic NIM Standard and Contact EMG Endotracheal Tubes
- Letter to Health Care Providers
|
|
July 8, 2024
Revoked Emergency Use Authorization
- cobas
SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the
cobas Liat System (Roche Molecular Systems, Inc.)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
MedSun
Newsletter - July 2024
Class
I Recall: An Implantable Hypoglossal Nerve Stimulator Device Removal:
Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse
Generator due to Manufacturing Defect That Can Result in System
Malfunctions
Class
I Recall: Radiofrequency (RF) Coils Correction: Philips North America
LLC Updates Use Instructions For SENSE XL Torso (1.5T And 3.0T)
Coils Due to a Potential Issue Where the Coil Heats Up During MRI
Scans, Possibly Leading to Thermal Injury
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Reclassification Petitions for Medical Devices
|
|
July 5, 2024
Reissued Emergency Use Authorizations
- SalivaDirect
DTC Saliva Collection Kit (SalivaDirect, Inc.)
- SalivaDirect
At-Home Collection Kit (SalivaDirect, Inc.)
Updated Emergency Use Authorizations
- Advin
COVID-19 Antigen Test @Home (Advin Biotech Inc.)
- WELLlife
COVID-19 / Influenza A&B Test (Wondfo USA Co., Ltd.)
- WELLlife
COVID-19 / Influenza A&B Home Test (Wondfo USA Co., Ltd.)
REdI
Conference (Updated)
|
|
July 3, 2024
Reissued Emergency Use Authorizations
- SalivaDirect
(SalivaDirect, Inc.)
- SalivaDirect
for use with DTC Kits (SalivaDirect, Inc.)
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
in Response to an Outbreak of Mpox
Federal
Register: Emergency Use Authorization: Monkeypox Polymerase Chain
Reaction Test Home Collection Kit in Response to an Outbreak of
Mpox
|
|
July 2, 2024
Public
Workshop - Food and Drug Administration/National Institutes of Health
Joint Workshop: Developing Implanted Brain-Computer Interface Clinical
Outcome Assessments to Demonstrate Benefit, September 19 and 20,
2024
|
|
July 1, 2024
CDRH
Statement: CDRH Announces Expansion of the Total Product Life Cycle
Advisory Program
Total
Product Life Cycle Advisory Program (TAP) (Updated)
|
| June 28, 2024
Class I Recall:
- Left
Ventricular Assist System (LVAS) Monitor Correction: Abbott Medical
Issues Correction for HeartMate LVAS System Monitor due to Screen
Issues that May Cause Unintentional Pump Stop
- Continuous
Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions
for OmniLab Advanced+ (OLA+) Ventilator due to Interruptions and/or
Loss of Therapy
Exemptions
From Electronic Product Regulations (Updated)
|
|
June 27, 2024
Revised Emergency Use Authorizations
- AdviseDx
SARS-CoV-2 IgG II - Abbott Laboratories Inc.
Updated Emergency Use Authorizations
- Cobas
liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test - Roche
Molecular Systems, Inc.
Class I Recall:
- Continuous
Ventilator Correction: Philips Respironics, Inc. Updates Use Instructions
for BiPAP V30, BiPAP A30, BiPAP A40 Due to Interruptions and/or
Loss of Therapy
- Ventilator
Correction: ZOLL Medical Corporation Updates Use Instructions For
731 Ventilators Due to Missing MRI Safety Information in The Labeling
That May Lead to Misuse and Ventilator Failure
Federal
Register: Diversity Action Plans To Improve Enrollment of Participants
From Underrepresented Populations in Clinical Studies; Draft Guidance
for Industry; Availability
|
|
June 26, 2024
eSTAR
Program (Updated)
CDRH
Announces Partnership to Develop New Methods to Accelerate Diagnostic
Device Development for Underserved Populations
Explore
Life at CDRH (Updated)
Medical
Device Sterilization Town Hall: Mock Pre-Submission on Implementing
a Change in Sterilization Method - July 10, 2024
|
|
June 25, 2024
Federal
Register: Laboratory Developed Tests: Small Entity Compliance Guide;
Guidance for Laboratory Manufacturers and Food and Drug Administration
Staff; Availability
|
|
June 24, 2024
Laboratory
Developed Tests: Small Entity Compliance Guide - Guidance for Laboratory
Manufacturers and Food and Drug Administration Staff
CDRH
Patient and Caregiver Connection (Updated)
|
| June 21, 2024
Consumer Information: LIAISON
Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus
B19 IgG Plus - P220034
(DiaSorin Inc.)
Consumer Information:
TriClip G4 System - P230007
(Abbott Medical)
Consumer Information: INTELLANAV
STABLEPOINT Ablation Catheter & Force Sensing System on The
RHYTHMIA HDX Mapping System - P150005/S074
(Boston Scientific Corporation)
|
|
June 20, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Home
as a Health Care Hub
Virtual
Public Meeting – Home as a Health Care Hub – Stakeholder
Listening Session; July 25, 2024
|
|
June 18, 2024
Consumer Information: Vercise
PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation Systems
- P150031/S064
(Boston Scientific Corporation)
Consumer Information: FoundationOne
CDx (F1CDx) - P170019/S048
(Foundation Medicine, Inc.)
Digital
Health Reports (Updated)
Laboratory
Developed Tests (Updated)
|
|
June 17, 2024
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
Blog:
The Promise Artificial Intelligence Holds for Improving Health Care
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
|
| June 14, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Consumer Information: AGENT
Paclitaxel-Coated Ballon Catheter - P230035
(Boston Scientific Corporation)
|
|
June 13, 2024
New Emergency Use Authorizations
- Healgen
COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) (Healgen
Scientific, LLC)
- Speedy
Swab Rapid COVID-19 + Flu A&B Antigen Self-Test (Watmind USA)
Transparency
for Machine Learning-Enabled Medical Devices: Guiding Principles
CDRH
Statement: CDRH Issues Guiding Principles for Transparency of Machine
Learning-Enabled Medical Devices
Class I Recall:
- Teleflex/Arrow
International Recall Arrow FiberOptix and UltraFlex Intra-Aortic
Balloon (IAB) Catheter Kits for Manufacturing Issue That May Prevent
Full Balloon Inflation and Cause Patient Harm
- Getinge
Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient
and Health Care Professional Exposure to Toxic Chemical Hydrogen
Fluoride
- Electrode
Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient
Return Electrodes for Risk of Serious Burn Injuries to Patients
|
|
June 12, 2024
Consumer Information: Alinity
m HR HPV for use on Alinity m System - P230003
(Abbott Molecular, Inc.)
Federal
Register: Request for Nominations for Individuals and Consumer Organizations
for Advisory Committees
|
|
June 11, 2024
New Emergency Use Authorizations
- iHealth
COVID-19/Flu A&B Rapid Test Pro (iHealth Labs, Inc.)
- cobas
liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (Roche
Molecular Systems, Inc.)
Updated Emergency Use Authorizations
- CorDx
TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test (CorDx,
Inc.)
Addressing
the Limitations of Medical Data in AI
Identifying
and Measuring AI Bias for Enhancing Health Equity
Evaluation
Methods for AI-enabled Medical Devices: Performance Assessment and
Uncertainty Quantification
Performance
Evaluation Methods for Evolving AI-Enabled Medical Devices
Regulatory
Evaluation of New Artificial Intelligence AI Uses for Improving
and Automating Medical Practices
Methods
for Effective Post-market Monitoring of AI-Enabled Medical Devices
eMDR
System Enhancements (Updated)
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Class
I Recall: Endotracheal Tube Recall: Medline Industries, LP Removes
Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to
Detachment or Tearing of the Inflation Tube from the Main Tube
Presentation
and Transcript added to Webinar - Enforcement Policies for Certain
In Vitro Diagnostic Devices - Draft Guidances, June 5, 2024
|
|
June 10, 2024
Artificial
Intelligence Program: Research on AI/ML-Based Medical Devices (Updated)
|
|
June 7, 2024
MedSun
Newsletter - June 2024
|
|
June 6, 2024
About
Manufacturer and User Facility Device Experience (MAUDE) Database
(Updated)
|
|
June 5, 2024
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
At-Home
COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
Class
I Recall: Medtronic Recalls StealthStation S8 Application Versions
1.2.0, 1.1.0, 1.0.3, 1.0.2, and 1.0.1 for Software Error that May
Cause Incorrect Measurements During Cranial Surgery
|
|
June 4, 2024
Revised Emergency Use Authorizations
- CorDx
Tyfast Flu A/B & COVID-19 Multiplex Rapid Test (CorDx, Inc.)
Consumer Information: TheraBionic
P1 - H220001
(TheraBionic, Inc.)
510(k)
Third Party Performance Metrics and Accreditation Status (Updated)
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Medical Device Recall Authority
|
|
June 3, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
|
| May 31, 2024
MDUFA
Reports: May 31, 2024, MDUFA V Performance Report
|
|
May 30, 2024
New Emergency Use Authorizations
- Speedy
Swab Rapid COVID-19 + Flu A&B Antigen Test (Watmind USA)
Class
I Recall: OptumHealth Care Solutions Recalls Nimbus II Infusion
Pump Systems Under Recall by InfuTronix, LLC
Mammography
Facility Inspection Fees (Updated)
Consumer Information: Abbott
Spinal Cord Stimulation (SCS) Systems - P010032/S191
(Abbott Medical)
|
|
May 29, 2024
Total
Product Life Cycle Advisory Program (TAP) (Updated)
CDRH
Petitions (Updated)
Medical
Device Sterilization Town Hall: Sterilization Open Q&A - 06/12/2024
Sterilization
for Medical Devices (Updated)
Consumer Information: Xstim
Spine Fusion Stimulator - P230025
(Xstim Inc.)
|
|
May 28, 2024
Updated Emergency Use Authorizations
- The
Nano Test for COVID-19 (Nanobiosym Precision Testing Services)
Revoked Emergency Use Authorizations
- Accula
SARS-Cov-2 Test (Mesa Biotech Inc.)
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: De Novo Classification Process (Evaluation of Automatic
Class III Designation)
|
| May 24, 2024
Consumer Information: Spectra WaveWriter, WaveWriter
Alpha and Alpha Prime Spinal Cord Stimulation Systems - P030017/S363
(Boston Scientific Corp.)
Revised Emergency Use Authorization
- QuickFinder
COVID-19/Flu Antigen Self Test (OSANG LLC)
- OHC
COVID-19/Flu Antigen Test Pro (OSANG LLC)
- WELLlife
COVID-19 / Influenza A&B Home Test (Wondfo USA Co., Ltd.)
Updated Emergency Use Authorization
- WELLlife
COVID-19 / Influenza A&B Test (Wondfo USA Co., Ltd.)
|
|
May 23, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Co-sponsored
Public Workshop - Using Patient-Generated Health Data in Medical
Device Development: Case Examples of Implementation Throughout the
Total Product Lifecycle - June 26-27, 2024
Standard
Operating Procedure (SOP) for Resolution of Internal Differences
of Opinion in Regulatory Decision-Making (Updated)
Class
I Recall: Vyaire Medical, Inc. Recalls the Twin Tube Due to The
Potential of The Nozzle Separating During Patient Use
|
|
May 22, 2024
Consumer Information: TZ
Medical Adult and Pediatric Multi-Function Defibrillation Electrodes
and Adaptors - P200005
(TZ Medical, Inc.)
Class
I Recall: Hologic, Inc. Recalls BioZorb Marker Due to Complications
with Implanted Devices
ASCA-Accredited
Testing Laboratories (Updated)
Consumer
Information: Duo Venous Stent System - P230021
(Vesper Medical, Inc.)
|
|
May 21, 2024
Consumer Information: restor3d
Total Talus Replacement - H230003
(restor3d, Inc.)
Materials
for May 23, 2024 Molecular and Clinical Genetics Panel of the Medical
Devices Advisory Committee Meeting
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Influenza
Diagnostic Tests
Federal
Register: Agency Information Collection Activities; Proposals, Submissions,
and Approvals: Yale-Mayo Clinic Centers of Excellence in Regulatory
Science and Innovation B12 Pediatric Device Survey
|
|
May 20, 2024
CDRH
Learn (Updated)
- Presentation and Transcript for Webinar - Final Rule: Medical
Devices; Laboratory Developed Tests - May 14, 2024
|
| May 17, 2024
Federal
Register: Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive
Device
|
|
May 16, 2024
Revised Emergency Use Authorization
- 3EO
Health COVID-19 Test (3EO Health, Inc.)
Qualification
of New Medical Device Development Tools (MDDT)
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Federal
Register: Revocation of Two Authorizations of Emergency Use of In
Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19;
Availability
|
|
May 15, 2024
Webinar
- Enforcement Policies for Certain In Vitro Diagnostic Devices -
Draft Guidances - June 5, 2024
Class
I Recall: Abbott Recalls HeartMate 3 Left Ventricular Assist System
(LVAS) Implant Kit for Risk of Blood Leakage or Air Entering System
Between Inflow Cannula and Apical Cuff
Class
I Recall: Draeger, Inc. Recalls Perseus A500 Anesthesia System for
Risk of Sudden Unexpected Shutdown When Used on Battery Power (Updated)
Federal
Register: Authorization of Emergency Use of Certain Medical Devices
During COVID-19; Availability
|
|
May 14, 2024
Laboratory
Developed Tests (Updated)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
|
| May 13, 2024
Artificial
Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
(Updated)
Class
I Recall: Philips Respironics, Inc. Recalls Trilogy Evo Continuous
Ventilators due to a Software-Related Possible Power Malfunction
|
| May 10, 2024
New Emergency Use Authorization
- iHealth
COVID-19/Flu A&B Rapid Test (iHealth Labs, Inc.)
Updated Emergency Use Authorization
- ImmuView
COVID-19 Antigen Home Test (CTK Biotech, Inc.)
Class
I Recall: Route 92 Medical Inc. Recalls Catheter due to Distal Tip
Separation at the Proximal Marker Band
|
|
May 9, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Remanufacturing
of Medical Devices - Guidance for Industry, Entities That Perform
Servicing or Remanufacturing, and Food and Drug Administration Staff
Webinar:
Final Guidance: Remanufacturing of Medical Devices - 06/27/2024
Remanufacturing
and Servicing Medical Devices (Updated)
Tips
to Help Charge Medical Devices Safely and Avoid Overheating
CDRH
Learn (Updated)
- Presentation and Transcript for Medical Device Sterilization Town
Hall: Topics and Formats for the Continuing Town Hall Series - April
29, 2024
- Presentation and Transcript for Draft Guidance: Select Updates
for the Premarket Cybersecurity Guidance: Section 524B of the FD&C
Act - April 30, 2024
Federal
Register: Remanufacturing of Medical Devices; Guidance for Industry,
Entities That Perform Servicing or Remanufacturing, and Food and
Drug Administration Staff; Availability
|
|
May 8, 2024
Why
Choose CDRH for Your Career? (Updated)
Explore
Life at CDRH (Updated)
Class
I Recall: Tandem Diabetes Care, Inc. Recalls Version 2.7 of the
Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2
Insulin Pump with Control-IQ Technology Prompted by a Software Problem
Leading to Pump Battery Depletion
Safety
and Quality Concerns with Getinge Cardiovascular Devices - Letter
to Health Care Providers
MedSun
Newsletter - May 2024
|
|
May 7, 2024
New Emergency Use Authorization
- WELLlife
COVID-19 / Influenza A&B Home Test
Revised Emergency Use Authorization
- STANDARD
Q COVID-19 Ag Test 2.0 (SD Biosensor, Inc.)
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
CDRH
Petitions (Updated)
|
|
May 6, 2024
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
|
|
May 3, 2024
Consumer Information: XACT
Carotid Stent System -
P040038/S043 (Abbott Vascular Inc.)
|
|
May 2, 2024
2024
Regulatory Education for Industry (REdI) Conference
Consumer Information: Paradise
Ultrasound Renal Denervation System - P220023
(Recor Medical, Inc.)
|
|
May 1, 2024
Revoked Emergency Use Authorization
- BD
Respiratory Viral Panel for BD MAX System (Becton, Dickinson and
Company (BD))
Consumer Information:
FoundationOne CDx Liquid (F1 Liquid CDx) - P190032/S011
(Foundation Medicine, Inc.)
List
of Cleared or Approved Companion Diagnostic Devices (In Vitro and
Imaging Tools) (Updated)
Qualification
of New Medical Device Development Tools (MDDT)
|
| April 30, 2024
Class
I Recall: BioMérieux Inc. Recalls VITEK 2 AST Kit due to
Incorrect Ceftriaxone Concentrations
Collaborative
Communities: Addressing Health Care Challenges Together (Updated)
Federal
Register: Laboratory Developed Tests
Federal
Register: Enforcement Policy for Certain In Vitro Diagnostic Devices
for Immediate Public Health Response in the Absence of a Declaration
under Section 564
|
|
April 29, 2024
Enforcement
Policy for Certain In Vitro Diagnostic Devices for Immediate Public
Health Response in the Absence of a Declaration under Section 564
- Draft Guidance for Laboratory Manufacturers and Food and Drug
Administration Staff
Consideration
of Enforcement Policies for Tests During a Section 564 Declared
Emergency - Draft Guidance for Industry and Food and Drug Administration
Staff
Webinar
- Final Rule: Medical Devices; Laboratory Developed Tests - May
14, 2024
Laboratory
Developed Tests: Frequently Asked Questions
Laboratory
Developed Tests (Updated)
Class
I Recall: SonarMed Inc. Recalls Airway Acoustic Sensors Due to a
Restricted Inner Diameter of Airway Causing Suction Catheter Passage
Difficulty
Class
I Recall: SonarMed Inc. Recalls Airway Monitors Due to a Software
Anomaly Resulting in Failure to Detect a Partial Obstruction in
2.5mm Sensors and Up To 3mm Distal to the Sensor Tip
Federal
Register: Laboratory Developed Tests
Federal
Register: Enforcement Policy for Certain In Vitro Diagnostic Devices
for Immediate Public Health Response in the Absence of a Declaration
under Section 564
Federal
Register: Consideration of Enforcement Policies for Tests During
a Section 564 Declared Emergency
|
|
April 27, 2024
Current
Career Opportunities at CDRH (Updated)
|
| April 26, 2024
Medical
Device Shortages List (Updated)
Class
I Recall: Elekta Instrument AB Recalls Disposable Biopsy Needle
Kit for Leksell Stereotactic System for Possibly Containing Microscopic
Stainless Steel Debris on the Inside of the Biopsy Needle
Printable
Slides for Webinar - Draft Guidance: Select Updates for the Premarket
Cybersecurity Guidance: Section 524B of the FD&C Act
|
|
April 25, 2024
Class
I Recall: Fresenius Medical Care Recalls Stay-Safe Catheter Extension
Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure
to Higher Than Allowable Levels of Toxic Compound NDL-PCBA
Class
I Recall: Outset Medical, Inc. Recalls Certain Tablo Hemodialysis
Systems for Risk of Patient Exposure to Higher Than Allowable Levels
of Toxic Compound NDL-PCBAs
Class
I Recall: Draeger, Inc. Recalls Perseus A500 Anesthesia System for
Risk of Sudden Unexpected Shutdown When Used on Battery Power
Class
I Recall: InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion
Pump Systems for Multiple Device Failures That May Cause Severe
Injury and Death
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
Printable
Slides: Medical Device Sterilization Town Hall: Topics and Formats
for the Continuing Sterilization Series - 04/29/2024
|
|
April 24, 2024
Class
I Recall: DeRoyal Industries, Inc. Recalls Tracecarts Containing
16FR Urine Meter Foley Under Recall by Nurse Assist
Transcript
and Summary Minutes for March 21, 2024: Ophthalmic Devices Panel
of the Medical Devices Advisory Committee Meeting Announcement -
03/21/2024
Meeting
Notice: May 23, 2024 Molecular and Clinical Genetics Panel of the
Medical Devices Advisory Committee
|
|
April 23, 2024
New Emergency Use Authorization
- WELLlife
Covid-19/Influenza A&B Test
CDRH
Statement: FDA Launches Health Care at Home Initiative to Help Advance
Health Equity
|
|
April 22, 2024
FDA
Encourages the Public to Follow Established Choking Rescue Protocols:
FDA Safety Communication
Federal
Register: Molecular and Clinical Genetics Panel of the Medical Devices
Advisory Committee, Guardant Shield Blood Collection Kit
|
| April 19, 2024
Updated Emergency Use Authorization
- The
AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL
Diagnostics, Inc., dba Anavasi Diagnostics)
Revoked Emergency Use Authorization
- FTD
SARS-CoV-2 (Fast Track Diagnostics Luxembourg S.à.r.l.)
Risks
with Exactech Equinoxe Shoulder System with Defective Packaging
- FDA Safety Communication (Updated)
|
|
April 17, 2024
CDRH
Statement: CDRH Issues 2024 Safety and Innovation Reports
Medical
Device Safety and Innovation Reports (Updated)
Current
Career Opportunities at CDRH (Updated)
Class
I Recall: Boston Scientific Recalls Obsidio Conformable Embolic
for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding
Class
I Recall: Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP
Software for Anomalies That Have the Potential to Cause Serious
Patient Harm or Death
|
|
April 16, 2024
CDRH
Unveils New Dataset to Help Improve Chemical Characterization Methods
for Biocompatibility of Medical Devices
Manufacturer
and User Facility Device Experience (MAUDE) (Updated)
CDRH
Petitions (Updated)
|
|
April 15, 2024
Revised Emergency Use Authorization
- Aptitude
Medical Systems Inc.: Metrix COVID-19 Test
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
Class
I Recall: Abbott/Thoratec Corp. Recalls HeartMate II and HeartMate
3 Left Ventricular Assist System (LVAS) due to Long-term Buildup
Causing an Obstruction
Medical
Device Sterilization Town Hall: Topics and Formats for the Continuing
Sterilization Series, April 29, 2024
Sterilization
for Medical Devices (Updated)
|
| April 11, 2024
MedSun
Newsletter - April 2024
Stress
Urinary Incontinence: Surgical Mesh Considerations and Recommendations
(Updated)
|
|
April 10, 2024
New Emergency Use Authorization
- CorDx
TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
FDA
Activities Related to Recalled Philips Ventilators, BiPAP Machines,
and CPAP Machines (Updated)
Foam
Testing Summary for Recalled Philips Ventilators, BiPAP Machines,
and CPAP Machines (Updated)
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
ASCA-Accredited
Testing Laboratories (Updated)
|
|
April 9, 2024
Problems
Reported With Essure (Updated)
Information
for Patients and Health Care Providers: Essure (Updated)
FDA
Activities Related to Essure (Updated)
|
|
April 8, 2024
New Emergency Use Authorization
- QuickFinder
COVID-19/Flu Antigen Self Test (OSANG LLC)
Re-issued Emergency Use Authorizations
- ePlex
Respiratory Pathogen Panel (GenMark Diagnostics, Inc.)
|
|
April 4, 2024
New Emergency Use Authorization
- SalivaNow
SARS-CoV-2 Assay (LMSI, LLC d/b/a Lighthouse Lab Services)
ASCA-Accredited
Testing Laboratories (Updated)
Class
I Recall:
Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator
Kits for a Malfunction Causing Non-Cycling, Continuous Positive
Gas Flow and Preventing Proper Ventilation
Class
I Recall: Medos International Sàrl Recalls Cerenovus CEREBASE
DA Guide Sheath due to Cracking of the Distal Catheter Shaft
Federal
Register: Device Good Manufacturing Practice Advisory Committee
Federal
Register: Voting Members for the Patient Engagement Advisory Committee
|
|
April 3, 2024
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication (Updated)
Class
I Recall: Teleflex and Arrow International Recall ARROW QuickFlash
Radial Artery and Radial Artery/Arterial Line Catheterization Kits
for Increased Resistance That May Lead to Vessel Injuries, Narrowing,
or Blockage
Reports
to Congress (Updated)
- FY 2021 Premarket Approval of Pediatric Uses of Devices
Medical
Device Development Tools (MDDT) (Updated)
|
|
April 2, 2024
Current
Career Opportunities at CDRH (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries - Sleep Apnea
Feature - DEN230041
|
|
April 1, 2024
CDRH
Learn (Updated)
- Presentation and Transcript for Medical Device Sterilization Town
Hall: The Value and Use of Recognized Consensus Standards in Premarket
Submissions - March 21, 2024
Standards
Newsletter from the Division of Standards and Conformity AssessmentExternal
Link Disclaimer
MQSA
National Statistics (Updated)
|
| March 29, 2024
eSTAR
Program (Updated)
|
|
March 28, 2024
Animal
Studies for Dental Bone Grafting Material Devices - Premarket Notification
(510(k)) Submissions - Draft Guidance for Industry and Food and
Drug Administration Staff
Co-sponsored
Public Meeting - Food and Drug Administration/Medical Device Innovation
Consortium Symposium on Computational Modeling and Simulation -
April 16-17, 2024
Mammography
Quality Standards Act and Program (Updated)
Mammography
Quality Standards Act - Facility Accreditation and Certification
(Updated)
Mammography
Quality Standards Act - Inspection Resources
Federal
Register: Animal Studies for Dental Bone Grafting Material Devices
- Premarket Notification (510(k)) Submissions
|
|
March 27, 2024
ASCA
Consolidated Pilot Final Report and 2023 Annual Report
Evaluation
of Automatic Class III Designation (De Novo) Summaries - Invitae
Common Hereditary Cancers Panel (DEN210011)
|
|
March 26, 2024
New Emergency Use Authorizations
- Labcorp
Monkeypox PCR Test Home Collection Kit (LabCorp)
- Non-variola
Orthopoxvirus Real-time PCR Primer and Probe Set - EUA (Centers
for Disease Control and Prevention (CDC))
Evaluation
of Automatic Class III Designation (De Novo) Summaries - Body Temperature
Software (BTS) (DEN230050), Sonu (DEN230045), X100 with Full Field
Bone Marrow Aspirate (BMA) Application, X100HT with Full Field Bone
Marrow Aspirate (BMA) Application (DEN230034)
Total
Product Life Cycle Advisory Program (TAP) (Updated)
|
|
March 25, 2024
CDRH
Statement: FDA Proposes New Ban of Electrical Stimulation Devices
for Self-Injurious or Aggressive Behavior
Medical
Device Bans (Updated)
Class
I Recall: Medline Industries Recalls Certain Kits and Trays Containing
Sterile Water Based Products Under Recall by Nurse Assist
24
Hour Summary and Presentations for March 21, 2024 Ophthalmic Devices
Panel of the Medical Devices Advisory Committee Meeting
Federal
Register: Banned Devices: Proposal to Ban Electrical Stimulation
Devices for Self-Injurious or Aggressive Behavior
|
| March 21, 2024
Class
I Recall: Abiomed Recalls the Instructions for Use for Impella Left
Sided Blood Pumps due to Perforation Risks
Class
I Recall: Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators
Due to Manufacturing Defect That Can Lead to Injury or Death
Breakthrough
Devices Program (Updated)
|
|
March 20, 2024
New Emergency Use Authorization
- EZ-SARS-CoV-2
Real-Time RT-PCR (Tetracore, Inc.)
Transcript
and Summary Minutes for February 13, 2024 Circulatory System Devices
Panel of the Medical Devices Advisory Committee Meeting
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
Federal
Register: Voluntary Total Product Life Cycle Advisory Program Pilot
|
|
March 19, 2024
CDRH
Statement: FDA Provides Update on Plastic Syringes Made in China,
Issues Warning Letters Related to Violative Products
UPDATE:
Evaluating Plastic Syringes Made in China for Potential Device Failures:
FDA Safety Communication
Materials
for March 21, 2024 Ophthalmic Devices Panel of the Medical Devices
Advisory Committee Meeting
|
|
March 18, 2024
Co-sponsored
Public Conference – Food and Drug Administration/Advanced Medical
Technology Association Medical Device Statistical Issues - April
2-3, 2024
|
| March 15, 2024
Artificial
Intelligence and Machine Learning in Software as a Medical Device
(Updated)
Consumer Information: Belotero
Balance® (+) - P090016/S050
(Merz North America, Inc.)
|
|
March 14, 2024
Evaluation
of Thermal Effects of Medical Devices that Produce Tissue Heating
and/or Cooling - Guidance for Industry and Food and Drug Administration
Staff
Requests
for Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program - Draft Guidance for Industry and Food and Drug Administration
Staff
Medical
Device Sterilization Town Hall: The Value and Use of Recognized
Consensus Standards in Premarket Submissions - March 21, 2024
Sterilization
for Medical Devices (Updated)
Class
I Recall: Avanos Recalls MIC Gastric – Jejunal Feeding Tube
Kits Containing Sterile Water Based Products Under Recall by Nurse
Assist
Federal
Register: Medical Devices; Technical Amendments
Federal
Register: Evaluation of Thermal Effects of Medical Devices That
Produce Tissue Heating and/or Cooling
Federal
Register: Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program
|
|
March 13, 2024
Federal
Register: Select Updates for the Premarket Cybersecurity Guidance:
Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft
Guidance for Industry and Food and Drug Administration Staff
|
|
March 12, 2024
Select
Updates for the Premarket Cybersecurity Guidance: Section 524B of
the FD&C Act - Draft Guidance for Industry and Food and Drug
Administration Staff
Webinar
- Draft Guidance: Select Updates for the Premarket Cybersecurity
Guidance: Section 524B of the FD&C Act - April 30, 2024
Cybersecurity
(Updated)
|
|
March 11, 2024
CDRH
Statement: CDRH Welcomes 25th Session of the International Medical
Device Regulators Forum
Collaborative
Communities: Addressing Health Care Challenges Together (Updated)
Class
I Recall: Windstone Medical Packaging, Inc. Recalls Local Lower
Extremity Pack, In House Ocular Pack and Closure Kit Containing
Sterile Water Based Products Under Recall by Nurse Assist
Class
I Recall: Abbott Recalls HeartMate Touch Communication System for
Unintentional Pump Start and Stop
|
| March 8, 2024
CDRH's
Experiential Learning Program (ELP) (Updated)
MDUFA
Reports (Updated)
- March 8, 2024, MDUFA V Performance Report
|
|
March 7, 2024
Updated Emergency Use Authorization
- The
AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL
Diagnostics, Inc., dba Anavasi Diagnostics)
MedSun
Newsletter - March 2024
Class
I Recall: Medtronic Neurosurgery Recalls Duet External Drainage
and Monitoring System Catheter Tubing due to a Potential for the
Catheter Disconnection from the Patient Line Stopcock Connectors
Class
I Recall: Ventec Life Systems Recalls VOCSN Patient Breathing Package
(Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded
Spiral Wrap
Class
I Recall: Cardinal Health Recalls Sterile Monoject Luer-Lock and
Enteral Syringes Due to a Change in Manufacturing (Updated)
CDRH
Learn (Updated)
- Presentation and Transcript for Medical Device Sterilization Town
Hall: FDA’s Modifications Guidances and the Use of Device Master
Files in Reviews - February 29, 2024
|
|
March 6, 2024
Dispositivos
médicos de realidad aumentada y realidad virtual: preguntas
que debe considerar
Augmented
Reality and Virtual Reality Medical Devices: Questions to Consider
(Updated)
Class
I Recall: Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400
Due to a Software Error
|
|
March 5, 2024
Medical
Device Single Audit Program (MDSAP) (Updated)
Class
I Recall: Smiths Medical ASD Inc. Recalls Medfusion Model 3500 Syringe
Pump Due to Issues Associated with Earlier Software Versions
Explore
Life at CDRH (Updated)
|
|
March 4, 2024
Federal
Register Documents (Updated)
Evaluation
of Automatic Class III Designation (De Novo) Summaries - OMNIgeneGUT
DX (DEN200040)
|
|
March 1, 2024
New Emergency Use Authorization
- OSOM
Flu SARS-CoV-2 Combo Test (SEKISUI Diagnostics, LLC)
- OSOM
Flu SARS-CoV-2 Combo Home Test (SEKISUI Diagnostics, LLC.)
Class
I Recall: Megadyne Medical Products, Inc. Recalls Mega Soft Universal
Patient Return Electrode Due to Reports of Patient Burns (Updated)
Class
I Recall: Datex-Ohmeda Recalls EVair Air Compressors Due to Formaldehyde
Emissions Found in Specific Conditions When Used with CARESCAPE
R860, Engstrom Carestation or Pro Ventilators
MQSA
National Statistics (Updated)
|
| February 29, 2024
Follow
Instructions for Safe Use of Electrical Operating Room Tables -
Letter to Health Care Providers
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA (Updated)
Transcript:
February 6, 2024 General Hospital and Personal Use Devices Panel
of the Medical Devices Advisory Committee Meeting
Class
I Recall: Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care
Plus models 1000-4000 and Lullaby Incubators Due to Problems with
Door Latch
Hintermann
Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk
of Device Failure: FDA Safety Communication
Federal
Register: Food and Drug Administration Modernization Act: List of
Recognized Standards, Recognition List Number: 061
|
|
February 28, 2024
Virtual
Public Workshop – Accreditation Scheme for Conformity Assessment
Expansion - April 17, 2024
Class
I Recall: Olympus Corporation of the Americas Recalls Bronchofiberscopes
and Bronchovideoscopes Because They Can Lead to Burns and Fire (Updated)
CDRH
Statement: CDRH’s Continued Commitment to Breast Implant Safety
Transcript
and Summary Minutes for February 2, 2024 Anesthesiology and Respiratory
Therapy Devices Panel of the Medical Devices Advisory Committee
Meeting
Federal
Register: Medical Device User Fee Cover Sheet and Device Facility
User Fee Cover Sheet
|
|
February 27, 2024
BioZorb
Markers and Potential Risks with Use in Breast Tissue: FDA Safety
Communication
|
|
February 26, 2024
Updated Emergency Use Authorization
- Abbott
RealTime Zika (Abbott Molecular Inc.)
Medical
Device Sterilization Town Hall: FDA’s Modifications Guidances
and the Use of Device Master Files in Reviews
|
| February 23, 2024
Revoked Emergency Use Authorizations
- xMAP
SARS-CoV-2 Multi-Antigen IgG Assay (Luminex Corporation)
|
|
February 22, 2024
Diagnostic
Data Program (Updated)
Systemic
Harmonization and Interoperability Enhancement for Laboratory Data
(SHIELD) (Updated)
Digital
Diagnostics: Over-the-Counter (OTC) and Point-of-Care (POC) (Updated)
|
|
February 21, 2024
Select
Updates for the Medical Device User Fee Small Business Qualification
and Certification Guidance - Guidance for Industry and Food and
Drug Administration Staff
Reduced
Medical Device User Fees: Small Business Determination (SBD) Program
(Updated)
Update:
Recommendations for Certain Medtronic Electromyogram Endotracheal
Tubes and Risk of Airway Obstruction - Letter to Health Care Providers
(Updated)
Do
Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels:
FDA Safety Communication
Federal
Register: List of Standing Committees: Digital Health Advisory Committee
Federal
Register: Select Updates for the Medical Device User Fee Small Business
Qualification and Certification Guidance; Agency Information Collection
Activities
|
|
February 20, 2024
Fraudulent
and Unreliable Laboratory Testing Data in Premarket Submissions:
FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated
Data
|
| February 15, 2024
Class
I Recall: Philips Recalls BrightView Imaging Systems Due to the
Detector Unexpectedly Falling
|
|
February 14, 2024
Class
I Recall: Smiths Medical ASD Inc. Recalls Medfusion Model 4000 Syringe
Pump Due to Issues Associated with Earlier Software Versions
|
|
February 13, 2024
Presentations
for February 2, 2024 Anesthesiology and Respiratory Therapy Devices
Panel of the Medical Devices Advisory Committee Meeting
|
| February 9, 2024
Materials
for February 13, 2024 Circulatory System Devices Panel of the Medical
Devices Advisory Committee Meeting
Presentations
for February 6, 2024 General Hospital and Personal Use Devices Panel
of the Medical Devices Advisory Committee Meeting
MedSun
Newsletter - February 2024
|
|
February 8, 2024
Current
Career Opportunities at CDRH
24
Hour Summary for February 2, 2024 Anesthesiology and Respiratory
Therapy Devices Panel of the Medical Devices Advisory Committee
Meeting
24
Hour Summary for February 6, 2024 General Hospital and Personal
Use Devices Panel of the Medical Devices Advisory Committee Meeting
|
|
February 7, 2024
International
Medical Device Regulators Forum (IMDRF) (Updated)
CDRH
International Affairs (Updated)
Consumer Information: Edwards
EVOQUE Tricuspid Valve Replacement System - P230013
(Edwards Lifesciences, LLC)
|
|
February 6, 2024
Updated Emergency Use Authorization
- The
AscencioDx COVID-19 Test and The AscencioDx Molecular Detector (ADL
Diagnostics, Inc.)
- iHealth
COVID-19 Antigen Rapid Test Pro (iHealth Labs, Inc.)
At-Home OTC COVID-19 Diagnostic Tests (Updated)
- BinaxNOW
COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
- Extended Expiration Date
Meeting
Notice: March 21, 2024 Ophthalmic Devices Panel of the Medical Devices
Advisory Committee
Recall
of Certain Saline and Sterile Water Medical Products Associated
with Nurse Assist: FDA Safety Communication (Updated)
Class
I Recall: Percussionaire Recalls High Frequency Transport Phasitron
Breathing Circuit Kits for Over-Pressurization
|
|
February 5, 2024
CDRH Learn (Updated)
- Presentation
and Transcript for Medical Device Sterilization Town Hall: FDA Activities
and Challenges in Reducing Reliance on Ethylene Oxide (EtO) - January
26, 2024
Federal
Register: Emergency Use Authorization: In Vitro Diagnostic Device
for Detection and/or Diagnosis of COVID-19; Revocation
Federal
Register: Hearings, Meetings, Proceedings, etc.: Ophthalmic Devices
Panel of the Medical Devices Advisory Committee, FSYX Ocular Pressure
Adjusting Pump System
|
|
February 2, 2024
Do
Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes
- FDA Safety Communication
At-Home
OTC COVID-19 Diagnostic Tests (Updated Xiamen Boson Biotech Co.,
Ltd. Rapid SARS-CoV-2 Antigen Test Card)
Materials
for February 6, 2024 General Hospital and Personal Use Devices Panel
of the Medical Devices Advisory Committee Meeting
|
|
February 1, 2024
Re-issued Emergency Use Authorizations
- Respiratory
SARS-CoV-2 RT-PCR Panel 1 (Revvity, Inc.)
- New
Coronavirus Nucleic Acid Detection Kit (Revvity, Inc.)
CDRH's
Experiential Learning Program (ELP) (Updated)
COVID-19 Tests Granted Traditional Marketing Authorization by the
FDA (Updated)
- Biofire®
Spotfire® Respiratory (R) Panel Mini (Biofire Diagnostics, LLC)
MQSA
National Statistics (Updated)
Total
Product Life Cycle Advisory Program (TAP) (Updated)
Medical
Device Shortages List (Updated)
Medical
Device Sterilization Town Hall: Discussion of Premarket Submission
Expectations and Additional Considerations for Sterility Review
- February 7, 2024
Federal
Register: Medical Devices; Quality System Regulation Amendments
|
| January 31, 2024
Materials
for February 2, 2024 Anesthesiology and Respiratory Therapy Devices
Panel of the Medical Devices Advisory Committee Meeting
Mammography
Quality Standards Act and Program (Updated)
Quality
Management System Regulation: Final Rule Amending the Quality System
Regulation – Frequently Asked Questions (Updated)
Quality
and Compliance (Medical Devices) (Updated)
Overview
of Device Regulation (Updated)
Quality
System (QS) Regulation/Medical Device Current Good Manufacturing
Practices (CGMP) (Updated)
Class
I Recall: Maquet Cardiovascular, LLC Recalls Atrium Express Dry
Suction Dry Seal Chest Drain Containing Sterile Water Based Products
Under Recall by Nurse Assist
Consumer Information: Aurora
EV-ICD System - P220012
(Medtronic, Inc.)
Problems
Reported with Recalled Philips Ventilators, BiPAP Machines, and
CPAP Machines (Updated)
CDRH
Announces Intent to Initiate the Reclassification Process for Most
High Risk IVDs
Federal
Register: Medical Devices; Quality System Regulation Amendments
|
|
January 30, 2024
Class
I Recall: Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy
Registration Fixture Due to a Calibration Error
|
|
January 29, 2024
Updated Emergency Use Authorization
- UOL
COVID-19 Test (Uh-Oh Labs Inc.)
CDRH
Statement on Philips’ Announcement
|
| January 26, 2024
ASCA-Accredited
Testing Laboratories (Updated)
Consumer Information - OncomineTM
Dx Target Test - P160045/S025
(Life Technologies Corporation)
|
|
January 25, 2024
Revised Emergency Use Authorization
- Rapid
SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
|
|
January 24, 2024
FDA
Elevates Office of Strategic Partnerships and Technology Innovation
to Super Office in CDRH
Recall of Certain Saline and Sterile Water Medical Products Associated
with Nurse Assist: FDA Safety Communication (Updated)
- Windstone
Medical Packaging dba Aligned Medical Solutions
Federal
Register: Emergency Use Authorization: Certain Medical Devices during
COVID-19
|
|
January 23, 2024
CLIA
Waiver by Application Decision Summaries (Updated)
Medical
Device Sterilization Town Hall: FDA Activities and Challenges in
Reducing Reliance on Ethylene Oxide (EtO)
|
|
January 22, 2024
Characterization
of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic
Devices - Draft Guidance for Industry and Food and Drug Administration
Staff
ASCA-Accredited
Testing Laboratories (Updated)
CDRH Learn (Updated)
- Presentation
and Transcript for Webinar - Assessing the Credibility of Computational
Modeling and Simulation in Medical Device Submissions Final Guidance
- January 11, 2024
Federal
Register: Characterization of Metallic Coatings and/or Calcium Phosphate
Coatings on Orthopedic Devices
|
| January 19, 2024
Meeting
Notice: February 13, 2024 Circulatory System Devices Panel of the
Medical Devices Advisory Committee
Ventilators
and Ventilator Accessories EUAs (Updated)
|
|
January 18, 2024
FDA
and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests,
Wherever They Are Made
CDRH Learn (Updated)
- Presentation
and Transcript for Medical Device Sterilization Town Hall: Overview
of Sterilization Landscape and Role of Ethylene Oxide - January
10, 2024
Certain
ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety
Issue with Magnets That May Affect Certain Medical Devices: FDA
Safety Communication
Historical
Information about Device Emergency Use Authorizations (Updated)
|
|
January 17, 2024
CDRH
2023 Annual Report
Recall
of Certain Saline and Sterile Water Medical Products Associated
with Nurse Assist: FDA Safety Communication (Updated)
CDRH
Petitions (Updated)
CLIA
Waiver by Application Decision Summaries (Updated)
|
|
January 16, 2024
Megadyne
Medical Products, Inc. Recalls Mega Soft Universal Patient Return
Electrode Due to Reports of Patient Burns (Updated)
Class
I Recall: ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical
Kit Due to Possible Lack of Sterility
Risks
with Exactech Equinoxe Shoulder System with Defective Packaging
- FDA Safety Communication
|
| January 12, 2024
Important
Information: Final Rule to Amend the Mammography Quality Standards
Act (MQSA)
Class
I Recall: Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump
(LVP) of the Ivenix Infusion System Due to Mechanical Interference
Report
to Congress: Device Pilot Projects FY 2022
|
|
January 11, 2024
Notifications
and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2
(Updated)
Class
I Recall: Busse Hospital Disposables, Inc. Recalls Care Trays and
Kits Containing Sterile Water Based Products Under Recall by Nurse
Assist
Class
I Recall: ResMed Ltd. Recalls Continuous Positive Airway Pressure
(CPAP) Masks with Magnets due to Possible Magnetic Interference
with Certain Medical Devices
|
|
January 10, 2024
V-CHAMPS
Challenge Winners
|
|
January 9, 2024
Potential
Exposure to Certain Chemicals with Use of GE HealthCare EVair and
EVair03 Compressors with Certain Ventilators – Letter to Health
Care Providers
Transcript
and Summary Minutes: November 29, 2023 Molecular and Clinical Genetics
Panel of the Medical Devices Advisory Committee Meeting
Transcript
and Summary Minutes: AMENDED INFORMATION: October 20, 2022 Clinical
Chemistry and Clinical Toxicology Devices Panel of the Medical Devices
Advisory Committee Meeting Announcement
At-Home
OTC COVID-19 Diagnostic Tests (Updated)
- InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.) -
Extended Expiration Date
|
|
January 8, 2024
Revised Emergency Use Authorization
- Advin
COVID-19 Antigen Test @Home (Advin Biotech Inc.)
Submission
and Review of Sterility Information in Premarket Notification (510(k))
Submissions for Devices Labeled as Sterile - Guidance for Industry
and Food and Drug Administration Staff (Updated)
Sterilization
for Medical Devices (Updated)
Transcript:
September 6, 2023 Patient Engagement Advisory Committee Meeting
Class
I Recall: Insulet Corporation Recalls Omnipod 5 Android App due
to a Software Error
Class
I Recall: Megadyne Medical Products, Inc. Recalls Mega Soft Universal
Patient Return Electrode Due to Reports of Patient Burns
Medical
Device Sterilization Town Hall: Overview of Sterilization Landscape
and Role of Ethylene Oxide - January 10, 2024
|
|
January 5, 2024
Recall
of Certain Saline and Sterile Water Medical Products Associated
with Nurse Assist: FDA Safety Communication (Updated)
|
|
January 4, 2024
ASCA-Accredited
Testing Laboratories (Updated)
|
|
January 3, 2024
Updated Emergency Use Authorizations
- Rapid
SARS-CoV-2 Antigen Test Card (Xiamen Boson Biotech Co., Ltd.)
- Lucira
by Pfizer COVID-19 & Flu Home Test (Pfizer Inc.)
Evaluation
of Airborne Chemicals from Neonatal Incubators - Letter to Health
Care Providers (Updated)
Do
Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication
|
|
January 2, 2024
Transition
to Electronic Export Documents - Letter to Industry
MedSun
Newsletter - January 2024
MQSA
National Statistics (Updated)
|
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.
|
|
