CDRHNew - News and Updates
April 29, 2022
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Consumer Information on: Agili-C – P210034
- Counterfeit At-Home OTC COVID-19 Diagnostic Tests
April 28, 2022
- Digital Health Policies and Public Health Solutions for COVID-19 (Updated)
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 20, 2022
- Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers
- Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users
April 27, 2022
April 26, 2022
- Class I Recall: Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use
- Medical Device User Fee Amendments 2023 (MDUFA V) (Updated - Industry Discussions on MDUFA V Reauthorization)
- FDA-Industry MDUFA V Reauthorization Meeting, March 7, 2022
- FDA-Industry MDUFA V Reauthorization Meeting, March 3, 2022
- FDA-Industry MDUFA V Reauthorization Meeting, March 2, 2022
- FDA-Industry MDUFA V Reauthorization Meeting, February 24, 2022
- FDA-Industry MDUFA V Reauthorization Meeting, February 22, 2022
- Medical Device Development Tools (MDDT) (Updated)
- New tool: FACE-Q Aesthetics
- Transcripts added to Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System - March 16 -17, 2022
April 25, 2022
- New Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- Re-issued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 4, May 18, June 1, June 15, and June 29
- Medical Device User Fee Amendments 2023 (MDUFA V) (Updated - Industry Discussions on MDUFA V Reauthorization)
- FDA-Industry MDUFA V Reauthorization Meeting, February 15, 2022
- FDA-Industry MDUFA V Reauthorization Meeting, February 10, 2022
- FDA-Industry MDUFA V Reauthorization Meeting, February 8, 2022
- FDA-Industry MDUFA V Reauthorization Meeting, February 3, 2022
- FDA-Industry MDUFA V Reauthorization Meeting, November 18, 2021
- FDA-Industry MDUFA V Reauthorization Meeting, November 9, 2021
- FDA-Industry MDUFA V Reauthorization Meeting, October 20, 2021
- FDA-Industry MDUFA V Reauthorization Meeting, October 7, 2021
- FDA-Industry MDUFA V Reauthorization Meeting, September 22, 2021
April 22,2022
- FAQs on Viral Transport Media During COVID-19 (Updated)
- STEM Career Opportunities at CDRH (Updated)
- Federal Register: General and Plastic Surgery Devices; Classification of the Autofluorescence Detection Device for General Surgery and Dermatological Use
- Federal Register: Medical Device User Fee Small Business Qualification and Certification
April 21,2022
- Consumer Information on: Aveir Leadless Pacing System – Aveir Leadless Pacemaker, Model LSP112V (Right Ventricular); Aveir Delivery Catheter, Model LSCD111; and Aveir Link Module, Module LSL02 – P150035
- Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff (Updated)
- Federal Register: Food and Drug Administration Modernization Act: Modifications to the List of Recognized Standards, Recognition List Number: 057
- Federal Register: Guidance: Compliance Policy Guides; Withdrawal
April 20, 2022
- Ventilators and Ventilator Accessories EUAs - Appendix B: Authorized Ventilators (Updated)
- Ventilators and Ventilator Accessories EUAs - Appendix B: Authorized Ventilator Accessories (Updated)
- Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration - June 7-9, 2022
- Resilient Supply Chain Program for Medical Devices
- Transcript for October 6, 2021 Patient Engagement Advisory Committee Meeting
April 19, 2022
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 6, 2022
- Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication
April 18, 2022
- New Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Consumer Information on: EVO/EVO+ VISIAN Implantable Collamer Lens – P030016/S035
- Consumer Information on: Et Control - P210018
- Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - 04/19/2022 (Updated Agenda)
April 15, 2022
- Breakthrough Devices Program
- Federal Register: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation
April 14, 2022
- New Emergency Use Authorizations
- In Vitro Diagnostics EUAs - Other Diagnostic Tests for SARS-CoV-2
April 13, 2022
- New Emergency Use Authorizations
- Re-issued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- CDRH Patient Engagement Advisory Committee (Updated)
- July 12-13, 2022: Patient Engagement Advisory Committee Meeting Announcement
- Federal Register: Meetings: Patient Engagement Advisory Committee
- Federal Register: Performance Criteria for Safety and Performance Based Pathway
April 12, 2022
- Denture Base Resins - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
- Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
April 11, 2022
- New Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers
April 8, 2022
- Surgical Sutures - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
- Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Staff
- 510(k) Third Party Performance Metrics and Accreditation Status (Added Performance Report for FY22, Q2)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Federal Register: Safety and Performance Based Pathway Device-Specific Guidances
April 7, 2022
- New Emergency Use Authorizations
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
April 6, 2022
- Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027
- Federal Register: Medical Devices; Humanitarian Use Devices
- Federal Register: Medical Device User Fee Amendments
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
April 5, 2022
- Reissued Emergency Use Authorizations
- Revisied Emergency Use Authorizations
- Medical Device Interoperability (Updated)
- Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
- Infections Associated with Reprocessed Duodenoscopes (Updated)
- Working Together to Improve Reusable Medical Device Reprocessing (Updated)
- MedSun Newsletter: April 2022, Volume 22, Issue 4
- Roster of the National Mammography Quality Assurance Advisory Committee (Updated)
April 4, 2022
- UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers
- ASCA-Accredited Testing Laboratories (Updated)
April 1, 2022
- MQSA National Statistics (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Scientific Fellowships at CDRH (Updated)
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 23, 2022
- CDRH Management Directory by Organization (Updated)
March 31, 2022
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results (Updated)
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- Consumer Information on: Evoke Spinal Cord Stimulation (SCS) System – P190002
March 30, 2022
- At-Home OTC COVID-19 Diagnostic Tests
March 29, 2022
- COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
- Device Evaluation Intern Program (CDRH) (Updated)
March 28, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Consumer Information on: Prometra Programmable Infusion Pump System - P080012/S068
- Requesting Speakers from CDRH (Updated)
- Federal Register: Technical Amendments