CDRHNew - News and Updates
September 22, 2021
- Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
- Medical Device Material Safety Summaries: ECRI Reports
- FDA In Brief: FDA Publishes Material Safety Data to Promote Safer, More Effective Medical Devices
- Class I Recall: Cordis Recalls Super Torque MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move or Dislodge
September 21, 2021
- Re-Issued Emergency Use Authorization
- Consumer Information on: VENTANA MMR RxDx Panel - P210001
- Virtual Public Workshop - Orthopedic Device-Related Infections II Workshop - December 3, 2021
- Consumer Information on: RelayPro Thoracic Stent-Graft System - P200045
September 20, 2021
September 17, 2021
- Updated Emergency Use Authorizations
- Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits - Letter to Clinical Laboratory Staff and Health Care Providers
- COVID-19 Tests and Collection Kits Authorized by the FDA: Infographic (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
September 16, 2021
September 15, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Stakeholder Consultation Meetings - Medical Device User Fee Amendments 2023 (MDUFA V) (Updated)
- Class I Recall: Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers
- Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices - Letter to Health Care Providers
- Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff
- Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19 (Updated)
- N95 Respirators, Surgical Masks, Face Masks, and Barrier Face Coverings (Updated)
September 13, 2021
September 10, 2021
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - September 22, 2021
- Two New CDRH Learn Modules: ¿Cómo se clasifica mi dispositivo médico? and Importación de Dispositivos Médicos a los Estados Unidos
- Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (Updated)
- Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions (Updated)
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
- Class I Recall: All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination
- Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination - Letter to Health Care Providers (Updated)
- ASCA-Accredited Testing Laboratories (Updated)
- Mammography Facility Adverse Event and Action Report - September 13, 2021: Hoffman Medical Center, a/k/a Hoffman MRI, f/k/a Hope Imaging and Medical Center, Inc.
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
- Federal Register: Consolidation of Devices That Process Autologous Human Cells, Tissues, and Cellular and Tissue-Based Products at the Point of Care to Produce a Therapeutic Article
September 9, 2021
- The CDC & FDA Antibiotic Resistance Isolate Bank (Updated)
- Consumer Information on: therascreen KRAS RGQ PCR Kit - P110027/S012
- N95 Respirators, Surgical Masks, and Face Masks (Updated)
September 8, 2021
- Revised Emergency Use Authorizations for Face Shields and Other Barriers
- MDSAP AU P0037.001 Guidelines on the use of GHTF/SG3/N19:2012 for MDSAP purposes
- CDRH's Customer Service Rating
September 7, 2021
- Reissued - Emergency Use Authorization
September 3, 2021
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
- Federal Register: Reclassification Petitions for Medical Devices
September 2, 2021
- August 2021 PMA Approval List
- MedSun Newsletter, September 2021
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210013, DEN210003, DEN200064 and DEN190056 added)
September 1, 2021
- #177, MedSun Newsletter, September 2021
- Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 4, 2021
- Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 11, 2021
- MQSA National Statistics (Updated)
August 31, 2021
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - September 8, 2021
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Removal Lists of Tests That Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
August 30, 2021
- New Emergency Use Authorizations
- Yale School of Public Health, Department of Epidemiology of Microbial Diseases
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Tracking Your Premarket Submission’s Progress (Progress Tracker)
August 27, 2021
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Denture Base Resins - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff
- Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff
- Federal Register: Safety and Performance Based Pathway Device-Specific Guidances
August 26, 2021
- New Emergency Use Authorization
- Updated Emergency Use Authorization
- Meeting Notice: October 20, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
- Meeting Notice: November 2-3, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee
- Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, New York: FDA Safety Communication
- Consumer Information on: Guardant360 CDx – P200010/S002
- Consumer Information on: ASSURE Wearable Cardioverter Defibrillator System Kit (P/N 80014-001), Monitor (P/N 80008-003), Therapy Cable (P/N 80004-003), Garment Style A (P/N 80015-XXX*) and Style B (P/N 80016-XXX*), Rechargeable Battery (P/N 3322882-005), Carry Pack (3326503-003), Battery Charger (3326633-004), Tablet (P/N 80041-001) – P200037
August 25, 2021
- Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng - Letter to Health Care Providers
- Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers
August 24, 2021
- Class I Recall: Bio-Medical Equipment Service Co. Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
- Virtual Public Workshop – Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices - October 14, 2021
- Medical Device Development Tools (MDDT) (Updated)
August 23, 2021
- Class I Recall: Cardinal Health Recalls Monoject Saline Flush Prefilled Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism
- ASCA-Accredited Testing Laboratories (Updated)