CDRHNew - News and Updates
June 16, 2022
- Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - 04/19/2022 (Updated)
- May 2022 PMA Approval List
June 15, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff
- CDRH Petitions (Updated)
- Federal Register: Administrative Procedures for Clinical Laboratory Improvement Amendments
- Federal Register: Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
June 14, 2022
- In Vitro Diagnostics EUAs - Other Tests for SARS-CoV-2 (Updated)
- In Vitro Diagnostics EUAs - Serology and Other Adaptive Immune Response Tests for SARS-CoV-2 (Updated)
- At-Home OTC COVID-19 Diagnostic Tests (Celltrion Diatrust Update)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220006 added)
- UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers (Updated)
- FDA's Ongoing Evaluation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Water-Based Heater-Cooler Devices (Updated)
- What is a Heater-Cooler Device? (Updated)
- Information for Patients (Updated)
- Recommendations for the Use of Water-Based Heater Cooler Devices (Updated)
June 13, 2022
- Prinatable Slides added - Webinar - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Draft Guidance
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200062 added)
June 10, 2022
- New Emergency Use Authroziations
- Revised Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- In Vitro Diagnostics EUAs - Other Tests for SARS-CoV-2 (Updated)
- Consumer Information on: GORE TAG Thoracic Branch Endoprosthesis – P210032
- Patient and Consumer Stakeholder Discussions on MDUFA V Reauthorization (September 2021 - March 2022 added)
June 9, 2022
- Reissued Emergency Use Authorizations
- 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
June 8, 2022
- Revised Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- Class I Recall: Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect
June 7, 2022
- FAQs on Testing for SARS-CoV-2 (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200035 added)
- Sterilization for Medical Devices (Updated)
- Transcript and Presentation added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - June 1, 2022
- #186, MedSun Newsletter, June 2022
- Accreditation Bodies: How to Participate in the ASCA Pilot (Updated)
- Testing Laboratories: How to Participate in the ASCA Pilot (Updated)
- How to Study and Market Your Device (Information about Consensus Standards)
- Accreditation Scheme for Conformity Assessment (ASCA) (Updated)
- Federal Register: Cardiovascular Devices; Classification of the Intravascular Bleed Monitor
- Federal Register: Safety and Effectiveness Summaries for Premarket Approval Applications
June 6, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Voluntary eSTAR Program (Updated)
- Federal Register: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices: Questions and Answers; Withdrawal
- Federal Register: Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation
June 3, 2022
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Consumer Information on: ENROUTE Transcarotid Stent System – P140026/S016
- Class I Recall: Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms
- Electromagnetic Compatibility (EMC) of Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Electromagnetic Compatibility (EMC) (Updated)
- Federal Register: Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices: Questions and Answers; Withdrawal
June 2, 2022
- UPDATE: FDA Updates Recommendations for the Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication
- Class I Recall: Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm
- Illumina Cybersecurity Vulnerability May Present Risks for Patient Results and Customer Networks: Letter to Health Care Providers
- Cybersecurity (Updated)
- 2nd Quarter FY 2022 MDUFA IV Performance Report
June 1, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Reissued and Revised Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- MQSA National Statistics (Updated)
May 31, 2022
- Consumer Information on: AccelStim Bone Growth Stimulator – P210035
- Federal Register: Cardiovascular Devices; Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals
May 27, 2022
- Meeting Notice: July 28-29, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
- Class I Recall: ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery
May 26, 2022
- Class I Recall: Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm
- Transcript and Presentation added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 18, 2022
- Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Postmarket Surveillance of Medical Devices
May 25, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- CDRH Management Directory by Organization (Updated)
May 24, 2022
- CDRH Petitions (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200019, and DEN200072 added)
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
May 23, 2022
- Consumer Information on: Alinity m CMV Assay - P210022
- Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication
- Federal Register: Emergency Use Authorization: In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Revocation
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