CDRHNew - News and Updates
May 20, 2022
- Consumer Information on: Thoraflex Hybrid - P210006
- Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration (Updated)
- Medical Devices and Radiation-Emitting Products Committee Vacancies (Updated)
- Roster of the Radiological Devices Panel (Updated)
- Roster of the General and Plastic Surgery Devices Panel (Updated)
- STEM Career Opportunities at CDRH (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
May 19, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210046 added)
- Webinar - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance - 06/14/2022
- Ethylene Oxide Sterilization for Medical Devices (Updated)
- Federal Register: 510(k) Sterility Change Master File Pilot Program
- Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (Updated)
- FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls (Updated)
May 18, 2022
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210044 added)
- Transcript added to Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - April 19, 2022
- Medical Device Material Safety Summaries (Updated)
- Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
- Consumer Information on: Organ Care System (OCS) Heart System – P180051/S001
May 17, 2022
May 16, 2022
- New Emergency Use Authorizations
- Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm (Updated)
- Class I Recall: Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA
May 13, 2022
- New Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation (Updated)
- Updated CDRH Learn Module: How is CDRH Structured?
- Class I Recall: Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm
May 11, 2022
- Consumer Information on: CardioMEMS HF System - P100045/S056
- Transcript and Presentation added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 4, 2022
May 10, 2022
- Do Not Use Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test: FDA Safety Communication
- Class I Recall: SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA
- Review Memos for Third Party 510(k) Reviewers
May 9, 2022
- Class I Recall: Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination
May 6, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Revoked Emergency Use Authorizatioins
- Updated Emergency Use Authorizations
- Potential Risk of Exposure to Toxic Compounds When Using Certain Hemodialysis Machines Manufactured by Fresenius Medical Care – Letter to Health Care Providers
- Federal Register: Revocation of Emergency Use Authorization: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19
May 5, 2022
- Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus - Guidance for Industry and Food and Drug Administration Staff
- Virtual Public Workshop - Animal Studies for Orthopedic Products - June 2, 2022
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200072 added)
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program - Draft Guidance for Industry and Food and Drug Administration Staff
- Voluntary Medical Device Manufacturing and Product Quality Pilot Program (Updated)
- Medtronic HeartWare Ventricular Assist Device (HVAD) System
- Federal Register: Cardiovascular Devices; Classification of the Reverse Central Venous Recanalization System
- Federal Register: Gastroenterology-Urology Devices; Classification of the Magnetically Maneuvered Capsule Endoscopy System
- Federal Register: General and Plastic Surgery Devices; Classification of the Mountable Electromechanical Surgical System for Transluminal Approaches
- Federal Register: Investigational Device Exemptions
- Federal Register: Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus
- Federal Register: Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement with the Voluntary Improvement Program
May 4, 2022
- Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff
- MedSun Newsletter: May 2022, Volume 22, Issue 5
May 3, 2022
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200063 added)
- MQSA National Statistics (Updated)
May 2, 2022
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health Inc.)
- Flowflex COVID-19 Antigen Home Test (ACON Laboratories, Inc.)
- OHC COVID-19 Antigen Self Test (OSANG LLC)
- Detect Covid-19 Test (Detect, Inc.)
- Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGI Genomics Co. Ltd)
- Xpert Xpress SARS-CoV-2 test (Cepheid)
- SARS-CoV-2 (N gene detection) Test (Exact Sciences Laboratories)
- IntelliPlex SARS-CoV-2 Detection Kit (PlexBio Co., Ltd.)
- TaqPath COVID-19 RNase P Combo Kit 2.0 (Thermo Fisher Scientific Inc.)
- Revised Emergency Use Authorizations
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200066 added)
- OHT8: Office of Radiological Health (New)
- Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions (Updated)
- Medical Device User Fee Amendments 2023 (MDUFA V)
- Federal Register: Administrative Detention and Banned Medical Devices
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