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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.
| March 28, 2025 - FDA
Approves Novel Treatment for Hemophilia A or B, with or without Factor
Inhibitors |
| March 28, 2025 - FDA
Roundup: March 28, 2025 |
| March 28, 2025 - FDA
Grants Marketing Authorization of First Home Test for Chlamydia, Gonorrhea
and Trichomoniasis |
| March 21, 2025 - FDA
Roundup: March 21, 2025 |
| March 20, 2025 - HHS,
FDA Announce Chemical Contaminants Transparency Tool for Foods |
| March 18, 2025 - HHS,
FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable,
and Nutritious Infant Formula for American Families |
| March 18, 2025 - FDA
Roundup: March 18, 2025 |
| March 14, 2025 - FDA
Educational Efforts Prevented Nearly 450,000 Youth from Starting E-Cigarette
Use in One Year |
| March 14, 2025 - FDA
Roundup: March 14, 2025 |
| March 11, 2025 - FDA
Roundup: March 11, 2025 |
| March 7, 2025 - FDA
Roundup: March 7, 2025 |
| March 4, 2025 - FDA
Roundup: March 4, 2025 |
| January 30, 2025 - FDA
Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain |
| January 17, 2025 - FDA
Roundup: January 17, 2025 |
| January 16, 2025 - FDA
Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive
Scientific Review |
| January 15, 2025 - FDA
Proposes Significant Step Toward Reducing Nicotine to Minimally or
Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco
Products |
| January 14, 2025 - FDA
Proposes Requiring At-a-Glance Nutrition Information on the Front
of Packaged Foods |
| January 14, 2025 - FDA
Roundup: January 14, 2025 |
| January 10, 2025 - FDA
Roundup: January 10, 2025 |
| January 7, 2025 - FDA
Roundup: January 7, 2025 |
| January 6, 2025 - FDA
Issues Draft Guidance on Including Tissue Biopsies in Clinical Trials |
| January 6, 2025 - FDA
Proposes Framework to Advance Credibility of AI Models Used for Drug
and Biological Product Submissions |
| January 6, 2025 - FDA
Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled
Medical Devices |
| January 6, 2025 - FDA
Proposes Updated Recommendations to Help Improve Performance of Pulse
Oximeters Across Skin Tones |
| January 3, 2025 - FDA
Roundup: January 3, 2025 |
For the most up to date FDA headlines, see the FDA
Medical Device News page.
| January 17, 2025
Revised Emergency Use Authorization
- Flowflex
Plus COVID-19 and Flu A/B Home Test (ACON Laboratories, Inc.)
At-Home OTC COVID-19 Diagnostic Tests
- Flowflex
Plus COVID-19 and Flu A/B Home Test (ACON Laboratories, Inc.) -
Extended Expiration Date
CDRH
2024 Annual Report
MedSun
Newsletter - January 2025
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January 16, 2025
CDRH
Statement: Medical Device Supply Chain Vulnerabilities and the Public
Health Impact They Have on Our Most Vulnerable Patients
Update:
Evaluation of Airborne Chemicals from Neonatal Incubators - Letter
to Health Care Providers
Early
Alert: Infusion Pump Software Issue from Fresenius Kabi USA
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January 15, 2025
Definitions
and General Oversight: Laboratory Developed Tests FAQs (Updated)
Phaseout
Policy and Enforcement Discretion Policies: Laboratory Developed
Tests FAQs (Updated)
Medical
Device Reporting, Complaints, and Corrections & Removals Reporting:
Laboratory Developed Tests FAQs (Updated)
Class
I Recall: Endoscopic Vessel Harvesting (EVH) System Correction:
Getinge and Maquet Cardiovascular Update Use Instructions for VasoView
HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent
or Detached Heater Wires and Silicone Peeling or Detaching During
Use
Total
Product Life Cycle Advisory Program (TAP) (Updated)
Accreditation
Scheme for Conformity Assessment (ASCA) (Updated)
- ASCA
2024 Annual Report
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January 14, 2025
Recognized
Consensus Standards Database (Updated)
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January 13, 2025
Revoked
Emergency Use Authorizations
- Access SARS-CoV-2 IgG (Beckman Coulter, Inc.)
- Access SARS-CoV-2 IgM (Beckman Coulter, Inc.)
- Access SARS-CoV-2 IgG II (Beckman Coulter, Inc.)
De Novo Decision Summary:
- DEN230027
- NaviCam ProScan
Premarket
Approval Application and Humanitarian Device Exemption Modular Review
- Guidance for Industry and FDA Staff
Class
I Recall: Outpatient Telemetry Correction: Philips Issues Correction
for Monitoring Service Application used with Mobile Cardiac Outpatient
Telemetry Due to Potential for Missed Information or Notifications
That May Impact Patient Care
Recalls,
Corrections and Removals (Devices) (Updated)
|
| January 8, 2025
COVID-19
Tests Granted Traditional Marketing Authorization by the FDA - Molecular
Diagnostic Tests (Updated)
- DASH SARS-CoV-2 & Flu A/B Test (Nuclein, LLC)
Getting
a Radiation Emitting Product to Market: Frequently Asked Questions
(Updated)
Webinar:
Investigational Use Requirements for In Vitro Diagnostic Products
(IVDs), including Laboratory Developed Tests (LDTs) Under 21 CFR
812 - February 25, 2025
Laboratory
Developed Tests (Updated)
Consumer Information: PyloPlus
UBT System - P170022/S003
(ARJ Medical Inc.)
Federal
Register: Requests for Nominations: Technical Electronic Product
Radiation Safety Standards Committee
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January 7, 2025
Consumer Information: Oncomine
Dx Target Test - P160045/S046
(Life Technologies Corporation)
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January 6, 2025
Pulse
Oximeters for Medical Purposes - Non-Clinical and Clinical Performance
Testing, Labeling, and Premarket Submission Recommendations - Draft
Guidance for Industry and Food and Drug Administration Staff
Pulse
Oximeters (Updated)
Validation
of Certain In Vitro Diagnostic Devices for Emerging Pathogens During
a Section 564 Declared Emergency - Draft Guidance for Industry and
Food and Drug Administration Staff
Artificial
Intelligence-Enabled Device Software Functions: Lifecycle Management
and Marketing Submission Recommendations - Draft Guidance for Industry
and Food and Drug Administration Staff
Evaluation
of Sex-Specific and Gender-Specific Data in Medical Device Clinical
Studies - Draft Guidance for Industry and Food and Drug Administration
Staff
Notifying
FDA of a Permanent Discontinuance or Interruption in Manufacturing
of a Device Under Section 506J of the FD&C Act - Guidance for
Industry and Food and Drug Administration Staff
Medical
Device Supply Chain and Shortages (Updated)
Supply
and Shortages of Medical Devices: Frequently Asked Questions (Updated)
506J
Device List (Updated)
Webinar
- Final Guidance: Notifying FDA of a Permanent Discontinuance or
Interruption in Manufacturing of a Device Under Section 506J of
the FD&C Act - March 4, 2025
Federal
Register: Artificial Intelligence-Enabled Device Software Functions:
Lifecycle Management and Marketing Submission Recommendations; Draft
Guidance for Industry and Food and Drug Administration Staff
Federal
Register: Validation of Certain In Vitro Diagnostic Devices for
Emerging Pathogens During a Section 564 Declared Emergency; Draft
Guidance for Industry and Food and Drug Administration Staff
Federal
Register: Pulse Oximeters for Medical Purposes - Non-Clinical and
Clinical Performance Testing, Labeling, and Premarket Submission
Recommendations; Draft Guidance for Industry and Food and Drug Administration
Staff
Federal
Register: Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the Federal Food, Drug, and Cosmetic Act; Guidance
for Industry and Food and Drug Administration Staff
Federal
Register: Evaluation of Sex-Specific and Gender-Specific Data in
Medical Device Clinical Studies; Draft Guidance for Industry and
Food and Drug Administration Staff
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| January 3, 2025
Federal
Register: Requests for Nominations: National Mammography Quality
Assurance Advisory Committee
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| January 2, 2025
Total
Product Life Cycle Advisory Program (TAP) (Updated)
MQSA
National Statistics (Updated)
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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.
- January
2025
- February 2025
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