November 18, 2021

• Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication (Updated)

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
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences)
  • cPass SARS-CoV-2 Neutralization Antibody Detection Kit (GenScript USA Inc.)
• 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
  • Revogene SARS-CoV-2 (Meridian Bioscience, Inc.)
• Reissued Emergency Use Authorizations
  • QuickVue SARS Antigen Test (Quidel Corporation)
• Revised Emergency Use Authorizations
  • Orawell IgM/IgG Rapid Test (Jiangsu Well Biotech Co., Ltd)
• Updated Emergency Use Authorizations
  • Talis One COVID-19 Test System (Talis Biomedical Corporation)
  • Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit (Thermo Fisher Scientific Inc.)
  • Flowflex COVID-19 Antigen Home Test (ACON Laboratories, Inc)
• 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
  • Talis One COVID-19 Test System (Talis Biomedical Corporation)
• Reissued Emergency Use Authorizations
  • Alinity m SARS-CoV-2 assay (Abbott Molecular Inc.)
  • BinaxNOW COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
• Updated Emergency Use Authorizations
  • LetsGetChecked Coronavirus (COVID-19) Test (LetsGetChecked, Inc.)
  • PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc.)
  • SGTi-flex COVID-19 IgG (Sugentech, Inc.)
  • MidaSpot COVID-19 Antibody Combo Detection Kit (Nirmidas Biotech, Inc.)
• Consumer Information on: Organ Care System (OCS) Liver – P200031
• Table of Pharmacogenetic Associations (Updated)

November 5 ,2021

• New Emergency Use Authorizations
  • iHealth COVID-19 Antigen Rapid Test
• 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
  • Detect Covid-19 Test (Detect, Inc.)
  • Boston Heart COVID-19 RT-PCR Test (Boston Heart Diagnostics)
• 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
  • Detect Covid-19 Home Test (Detect, Inc.)
• 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
  • Celltrion DiaTrust COVID-19 Ag Home Test (Celltrion USA, Inc.)
  • QuickVue At-Home OTC COVID-19 Test (Quidel Corporation)
  • SCoV-2 Detect Neutralizing Ab ELISA (InBios International, Inc.)
• Reissued Emergency Use Authorizations
  • SelfCheck cobas SARS-CoV-2 Assay (G Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute)
• Updated Emergency Use Authorizations
  • cobas SARS-CoV-2 (Roche Molecular Systems, Inc.)
  • cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
  • TaqPath COVID-19 Fast PCR Combo Kit 2.0 (Life Technologies Corporation (a part of Thermo Fisher Scientific Inc.))
  • Xpert Xpress CoV-2/Flu/RSV plus (Cepheid)
• 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)

October 21, 2021

• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210005 added)

October 20, 2021

• Updated Emergency Use Authorizations
  • Flowflex COVID-19 Antigen Home Test (ACON Laboratories)
  • QuickVue At-Home OTC COVID-19 Test (Quidel Corporation)
  • Zika Virus Detection by RT-PCR Test (ARUP Laboratories)
  • Zika MAC-ELISA (CDC)
  • Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)
• Medical Device Reporting (MDR): How to Report Medical Device Problems (Updated)
• Presentation Slides added to Virtual Public Workshop - Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices - October 14, 2021

October 19, 2021

• Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff
• Hearing Aids (Updated)
• Other Hearing Devices and Products (Updated)
• Webinar on Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
• Federal Register: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Availability
• Federal Register: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids

October 18, 2021

• New Emergency Use Authorizations
  • CovidNow SARS-CoV-2 Assay (LMSI, LLC (dba Lighthouse Lab Services))
• Reissued Emergency Use Authorizations
  • Gravity Diagnostics SARS-CoV-2 RT-PCR (Gravity Diagnostics, LLC)
  • Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits (Gravity Diagnostics, LLC)
• Updated Emergency Use Authorizations
  • Flowflex COVID-19 Antigen Home Test (ACON Laboratories, Inc)
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 20, 2021
• Studies Using Leftover, Deidentified Human Specimens Require IRB Review – Letter to Industry
• Materials for October 20, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting

October 14, 2021

• New Emergency Use Authorizations
  • SPERA COVID-19 Ag Test (Xtrava Health)
• Reissued Emergency Use Authorizations
  • TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
  • Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit (Thermo Fisher Scientific, Inc.)
• Updated Emergency Use Authorizations
  • Quest Diagnostics PF SARS-CoV-2 Assay (Quest Diagnostics Infectious Disease, Inc.)
  • BinaxNOW COVID-19 Antigen Self Test (Abbott Diagnostics Scarborough, Inc.)
• Class I Recall: Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results
• 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 (Updated)
• Video and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - October 6, 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)