CDRH New - News and Updates
A comprehensive list of the latest CDRH updates.
March 12, 2026
- Medical Devices with Indications Associated with Weight Loss Guidance - Guidance for Industry and Food and Drug Administration Staff
- FDA Activities: Weight-Loss and Weight-Management Devices (Updated)
- Federal Register: Medical Devices with Indications Associated with Weight Loss--Premarket Considerations
March 11, 2026
March 10. 2026
- Early Alert: Flexible Cryoprobe Issue from Erbe USA
- Town Hall – Medical Device Risk-Based Inspections
March 9, 2026
- Catch up on the latest issues of CDRH’s MedSun newsletter
March 6, 2026
March 5, 2026
- Catheter Recall: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters (Updated)
- Catheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
March 4, 2026
- Artificial Intelligence-Enabled Medical Devices (Updated)
- Medical Devices that Incorporate Sensor-based Digital Health Technology (Updated)
- Augmented Reality and Virtual Reality in Medical Devices (Updated)
- Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols - FDA Safety Communication
March 3, 2026
February 26, 2026
February 25, 2026
- Early Alert: Heart Pump Purge Cassette Issue from Abiomed
- Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software
- Stent Recall: Boston Scientific Removes Certain AXIOS Stents and Electrocautery-Enhanced Delivery Systems
- Meeting Minutes: FDA-Industry MDUFA VI Reauthorization Meeting, February 4, 2026
February 24, 2026
- Re-issued Emergency Use Authorizations
- Visby Medical, Inc. - Visby Medical Respiratory Health Test
- Revised Monkeypox (mpox)Emergency Use Authorizations
- Roche Molecular Systems, Inc. - cobas MPXV for use on the cobas 6800/8800 Systems (cobas MPXV)
- Updated Emergency Use Authorizations for Medical Devices
- CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A(H7) [Eurasian Lineage] Assay (CDC)
- 1st Quarter FY 2025 MDUFA V Performance Report
February 23, 2026
- Insufflation Unit Recall: Olympus Removes High Flow Insufflation Units
- Meeting Minutes: FDA-Industry MDUFA VI Reauthorization Meeting, January 21, 2026
- Revised Emergency Use Authorizations
- ACON Laboratories, Inc. - Flowflex Plus COVID-19 and Flu A/B Home Test
- Wondfo USA Co., Ltd - WELLlife COVID-19 / Influenza A&B Home Test
- Wondfo USA Co., Ltd - WELLlife COVID-19 / Influenza A&B Test
- SEKISUI Diagnostics, LLC - OSOM Flu SARS-CoV-2 Combo Test
- SEKISUI Diagnostics, LLC - OSOM Flu SARS-CoV-2 Combo Home Test
- iHealth Labs, Inc. - iHealth COVID-19/Flu A&B Rapid Test Pro
- iHealth Labs, Inc. - iHealth COVID-19/Flu A&B Rapid Test
- CorDx, Inc. - CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test
- CorDx, Inc. - CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test
- Updated Emergency Use Authorizations
- CorDx, Inc. - CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test (Shelf Life)
- SEKISUI Diagnostics, LLC - OSOM Flu SARS-CoV-2 Combo Home Test (Extended Expiration Date)
February 18, 2026
- Federal Register: Revocation of Authorization of Emergency Use of ExThera Medical Corporation Seraph 100 Microbind Affinity Blood Filter (Seraph 100); Availability
- Federal Register: Food and Drug Administration Modernization Act: Modifications to the List of Recognized Standards, Recognition List Number: 065
February 17, 2026
- Early Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems
- Town Hall – Clinical Decision Support Software, Final Guidance
- GUDID Data Trends - May 2025, September 2025, and December 2025
- Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products Requirements
February 13, 2026
February 10, 2026