CDRHNew - News and Updates
May 17, 2021
- Problems Reported with Essure
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 12, 2021
May 15, 2021
May 14, 2021
- Notice of Meeting: June 3-4, 2021 Neurological Devices Panel of the Medical Devices Advisory Committee
- May 2021 MedSun Newsletter
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
May 13, 2021
- Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 19, 2021
- Facility Certification and Inspection Mammography Quality Standards Act (MQSA): Inspection Fees (Updated)
- Class I Recall: Abbott (formally known as “St. Jude Medical”) Recalls Assurity™ and Endurity™ Pacemakers for Potential Moisture Ingress Causing Electrical Short and Reduced Battery Life
- Magnets in Cell Phones and Smart Watches May Affect Pacemakers and Other Implanted Medical Devices
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Federal Register: Meetings: Neurological Devices Panel of the Medical Devices Advisory Committee
May 12, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Class I Recall: Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues
May 11, 2021
- Presentations added to Virtual Public Meeting - Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices - May 4, 2021
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 5, 2021
May 7, 2021
- New Emergency Use Authorizations
- Re-issued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- BioFire COVID-19 Test (BioFire Defense, LLC)
- SalivaDirect At-Home Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
- Aptima SARS-CoV-2/Flu assay (Hologic, Inc.)
- Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit (Bio-Rad Laboratories, Inc.)
- Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.)
- Appendix A: Authorized Surgical Masks
May 6, 2021
- New Emergency Use Authorizations
- Transcript and Summary Minutes for April 6, 2021 Circulatory Devices Panel of the Medical Devices Advisory Committee Meeting
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms
May 5, 2021
- Re-issued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device Submissions - May 20, 2021
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200019 added)
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 28, 2021
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 12, 2021
- Consumer Information on: Medtronic Harmony Transcatheter Pulmonary Valve (TPV) System - P200046
- Transcript for March 23, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
May 4, 2021
- New Emergency Use Authorizations
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Medical Device Types to Help Determine Section 506J Notification Obligations (Update)
May 3, 2021
- Information about Automated Endoscope Reprocessors (AERs) and FDA's Evaluation (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
April 30, 2021
- Updated Emergency Use Authorizations
- BD SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company (BD))
- BD SARS-CoV-2/Flu for BD MAX System (Becton, Dickinson and Company (BD))
- Genetrack SARS-CoV-2 Molecular Assay (Genetrack Biolabs, Inc.)
- DxTerity SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)
- AQ-TOP COVID-19 Rapid Detection Kit PLUS (SEASUN BIOMATERIALS, Inc.)
- Revised Emergency Use Authorizations
- Re-issued Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- Class I Recall: Pacific Medical Group (DBA Avante Health Solutions) Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- MQSA Inspection Billing Invoice Process Going Electronic
April 29, 2021
- Updated Emergency Use Authorizations
- Consumer Resources (Updated)
- Virtual Public Workshop - Orthopedic Device Postmarket Review - June 10, 2021
- Sharps Disposal Containers in Health Care Facilities
- 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)
April 28, 2021
- Updated Emergency Use Authorizations
- EUA Authorized Serology Test Performance (Updated)
- Medical Device User Fee Amendments (MDUFA) (Updated)
- ASCA-Accredited Testing Laboratories (Updated)
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 5, 2021
- Federal Register: Medical Device Reporting
- Federal Register: Modifications to the List of Recognized Standards, Recognition List Numbers: 055
April 27, 2021
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 21, 2021
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
April 26, 2021
- Re-issued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- 510(k) Program Pilots (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)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200046 added)
April 23, 2021
- Cordis Recalls Precise PRO Rx US Carotid System Due to Risk of Separation in Device During Use
- FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic (Updated)
- Importing Medical Devices During the COVID-19 Pandemic (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
April 22, 2021
- New Emergency Use Authorizations
- Re-issued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Federal Register: Authorization of Emergency Use of Certain Medical Devices During COVID-19
April 21, 2021
- Updated Emergency Use Authorizations
- Presentations and Transcripts added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 2, 2020 and April 14, 2021
- New CDRH Learn Modules: How to Use Consensus Standards in Premarket Submissions and The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 28, 2021
April 20, 2021
- New Emergency Use Authorizations
- Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop
- Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - April 27, 2021
April 19, 2021
- New Emergency Use Authorizations
- SynergyDx SARS-CoV-2 RNA Test DTC (Synergy Diagnostic Laboratory, Inc., DBA SynergyDx)
- SynergyDx SARS-CoV-2 RNA Test (Synergy Diagnostic Laboratory, Inc., DBA SynergyDx)
- Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
- Healthcare Pro Surgical Masks (BLUETRACK, Inc.)
- 3 Ply Surgical Mask (Manohar Filaments Private Limited)
- Reissued Emergency Use Authorizations
- Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Posts
- FDA-Industry MDUFA V Reauthotization Meeting, March 17, 2021
- Summary Minutes for October 27, 2020 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
- Consumer Information on: Simplify® Cervical Artificial Disc – P200022/S003
April 16, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Revised Emergency Use Authorizations
- The FDA issues final rule amending medical device classification regulations, excluding non-device software functions
- Class I Recall: CareFusion 303, Inc. Recalls BD Alaris Pump Module Model 8100 Due to Risk of Stuck or Unresponsive Keys
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Federal Register: Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures Act
April 15, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Federal Register: Medical Devices: Class I Surgeon's and Patient Examination Gloves
- Federal Register: Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices from Premarket Notification Requirements; Withdrawal of Proposed Exemptions
- New CDRH Learn Module - MDSAP: Production and Service Controls Process: Part 3
- Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
- Class I Recall: Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports
April 14, 2021
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 21, 2021
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
April 13, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorization
- New CDRH Learn Module - MDSAP: Production and Service Controls Process: Part 2
- 24 Hour Summary for April 6, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200055 added)