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March 18, 2026

• Early Alert: Surgical Stapler Issue from Intuitive Surgical
• Early Alert: Insulin Pump Issue from Insulet
• Early Alert: Handy Solutions Neck & Shoulders Heating Pad Issue from Navajo Manufacturing Company
• Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification Procedures

March 17, 2026

• Federal Register: Medical Devices; Radiology Devices; Classification of Blood Irradiators
• Federal Register: Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended to Prevent Metastasis

March 16, 2026

• Report to Congress: Postmarket Device Safety-Related Communications
• Dialysis Tubing Set Correction: Vantive Updates Use Instructions for Prismaflex and Oxiris Sets
• Convenience Kit Recall: Integra LifeSciences Removes Tuohy Needle

March 13, 2026

• Presentation, Slides, and Transcript added to Town Hall – Clinical Decision Support Software, Final Guidance, March 11, 2026
• Federal Register: General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; Withdrawal

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

• Meeting Minutes: FDA-Industry MDUFA VI Reauthorization Meeting, February 18, 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

• Wound and Burn Dressing Recall: Integra LifeSciences Removes Certain MediHoney and CVS Wound and Burn Products

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

• Meeting Minutes: FDA-Industry MDUFA VI Reauthorization Meeting, February 11, 2026

February 2026

February 26, 2026

• Presentation, Slides, and Transcript for Town Hall – Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final Guidance, February 18, 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

• Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds

February 10, 2026

• Meeting Minutes: FDA-Industry MDUFA VI Reauthorization Meeting, January 21, 2026