CDRHNew - News and Updates
November 22, 2021
- New Emergency Use Authorizations
- Reissused Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
November 19, 2021
- Safely Using Sharps (Needles and Syringes) at Home, at Work and on Travel (Updated)
- Reclassification (Updated)
- FDA In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Federal Register: Effective Date of Requirement for Premarket Approval for Blood Lancets
- Federal Register: General and Plastic Surgery Devices; Reclassification of Blood Lancets
- Federal Register: Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests
- Federal Register: Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests
- Federal Register: Administrative Detention and Banned Medical Devices
November 18, 2021
- Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication (Updated)
- Federal Register: Guidance: Website Location of Center for Devices and Radiological Health Fiscal Year 2022
November 17, 2021
- MDUFA IV Performance Report - 4th Quarter FY2021
- Leadless Pacing Systems: Risk of Major Complications Related to Cardiac Perforation During Implantation - Letter to Health Care Providers
November 16, 2021
- Medical Device Development Tools (MDDT) (Updated)
November 15, 2021
- Reissued Emergency Use Authorizations
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Guidance for Developers and Food and Drug Administration Staff
- Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) - Guidance for Commercial Manufacturers, Clinical Laboratories, and Food and Drug Administration Staff
- Coronavirus (COVID-19) and Medical Devices (Updated)
- FAQs on Testing for SARS-CoV-2 (Updated)
- Reissued the EUA for Molecular Diagnostic Tests for SARS-CoV-2 Developed And Performed By Laboratories Certified Under CLIA To Perform High Complexity Tests
- Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing
- FDA News Release: Coronavirus (COVID-19) Update: FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests
- Consumer Information on: Vercise™ PC, Vercise Gevia™ and Vercise Genus™ Deep Brain Stimulation (DBS) System - P150031/S040
- Consumer Information on: Ki-67 IHC MIB-1 pharmDx (Dako Omnis) - P210026
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210006 added)
November 12, 2021
- Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication
- Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions (Updated)
November 10, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Consumer Information on: ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters – P200004
- Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results
- Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety (Updated)
- Activities to Support Medical Device Innovators (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200033 added)
November 9, 2021
- Molecular and Antigen Home Use Test Template (Updated)
- 24 Hour Summaries posted for November 2-3, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
- Class I Recall: Aligned Medical Solutions Doing Business as Windstone Medical Packaging, Inc. Recalls Custom Convenience Kits Due to Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) Plunger Defect
November 8, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Consumer Information on: Organ Care System (OCS) Liver – P200031
- Table of Pharmacogenetic Associations (Updated)
November 5 ,2021
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Personal Protective Equipment EUAs (Update to Appendix A)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190028 and DEN200040 added)
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 20, 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)
November 4, 2021
- Cybersecurity (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN180007 added)
November 3, 2021
- Content of Premarket Submissions for Device Software Functions - Draft Guidance for Industry and Food and Drug Administration Staff
- Webinar - Draft Guidance: Content of Premarket Submissions for Device Software Functions - December 16, 2021
- Federal Register: Content of Premarket Submissions for Device Software Functions
November 2, 2021
- Nucleic Acid Based Tests (Updated)
November 1, 2021
- Updated Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Aptima SARS-CoV-2 assay (Hologic, Inc.)
- Aptima SARS-CoV-2/Flu assay (Hologic, Inc.)
- SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
- SalivaDirect for use with DTC Kits (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
- LumiraDx SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
- Status COVID-19/Flu (Princeton BioMeditech Corp.)
- InteliSwab COVID-19 Rapid Test (OraSure Technologies, Inc.)
October 29, 2021
- Medical Gloves for COVID-19 (Updated)
- Materials posted for November 2-3, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
- Class I Recall: Zimmer Biomet Recalls ROSA One 3.1 Brain Application Due to Error in Software
- Class I Recall: Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure
- Dental Implants: What You Should Know
- 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)
- FAQs on Viral Transport Media During COVID-19 (Updated)
October 28, 2021
- New Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Personal Protective Equipment EUAs (Update to Appendix A)
October 27, 2021
- Good Machine Learning Practice for Medical Device Development: Guiding Principles
- Breast Implant Postmarket Safety Information
- Breast Implants (Updated)
- Labeling for Approved Breast Implants (Updated)
- FDA News Release: FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants
- Federal Register: Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
- Federal Register: Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
October 26, 2021
- CDRH Proposed Guidances for Fiscal Year 2022 (FY2022)
- CDRH Proposed Guidance Development (Updated)
- Federal Register: Guidance: Website Location of Center for Devices and Radiological Health Fiscal Year 2022
- Meeting Notice: December 10, 2021 Neurological Devices Panel of the Medical Devices Advisory Committee
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - November 17, December 1, and December 15, 2021 (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
October 25, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- In Vitro Diagnostics EUAs (Updated)
- Decorative Contact Lenses for Halloween and More (Updated)
- Endometrial Ablation for Heavy Menstrual Bleeding
- Federal Register: Neurological Devices Panel of the Medical Devices Advisory Committee
October 22, 2021
- 24 Hour Summary for October 20, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
- Transcript and Summary Minutes for July 14, 2021 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting
- 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)