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)

October 13, 2021

• Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
• UDI Rule and Guidances, Training, Resources, and Dockets (Updated)
• GUDID Guidance (Updated)
• Unique Device Identification System (UDI System) (Updated)
• UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers
• FDA's Ongoing Evaluation and Continued Monitoring of Reports of Nontuberculous Mycobacteria Infections Associated with Heater-Cooler Devices (Updated)
• What Is a Heater-Cooler Device? (Updated)
• Third Party Performance Report - FY21, Q4
• Federal Register: Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices

October 12, 2021

• New Emergency Use Authorization
  • Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute
  • PerkinElmer, Inc.
  • Quest Diagnostics Infectious Disease, Inc.
    • Quest Diagnostics Collection Kit for COVID-19 10/08/2021
  • Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDA’s Response
• Updated Emergency Use Authorization
  • EUROIMMUN US, Inc.
  • DiaSorin Inc.
• Re-issued Emergency Use Authorization
  • Quest Diagnostics Infectious Disease, Inc.
    • Quest Diagnostics HA SARS-CoV-2 Assay 
    • Quest Diagnostics RC SARS-CoV-2 Assay 
    • Quest Diagnostics PF SARS-CoV-2 Assay 
• 24 Hour Summary for October 6, 2021 Patient Engagement Advisory Committee Meeting
• Potential for Medication Overdose with ENFit Low Dose Tip Syringe: FDA Safety Communication

October 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)
• Video and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - September 22, 2021
• Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA Safety Communication
• Dermal Fillers (Soft Tissue Fillers) (Updated)
• Reclassification (Updated)

October 7, 2021

• Surgical Staplers and Staples for Internal Use - Labeling Recommendations - Guidance for Industry and Food and Drug Administration Staff
• UPDATE: Safe Use of Surgical Staplers and Staples - Letter to Health Care Providers
• Surgical Staplers and Staples (Updated)
• Federal Register: General and Plastic Surgery Devices: Reclassification of Certain Surgical Staplers
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Labeling Regulations
• Federal Register: Guidance: Surgical Staplers and Staples for Internal Use--Labeling Recommendations
• First Database of Tumor Mutations Recognized by the FDA as a Scientifically Valid Source for Test Developers

October 6, 2021

• Class I Recall: DeRoyal Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set 
• In Vitro Diagnostics EUAs (Updated)
• Class I Recall: Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use

October 5, 2021

• New Emergency Use Authorization
  • Laboratory Corporation of America (Labcorp)
  • EUROIMMUN US, Inc.
• Updated
  • Abbott Laboratories Inc.
  • Siemens Healthcare Diagnostics Inc.
  • Zika Virus Detection by RT-PCR Test (ARUP Laboratories)
  • Zika MAC-ELISA (CDC)
  • Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics)
  • Zika Virus Real-time RT-PCR Test (Viracor Eurofins)

• Cybersecurity Awareness Month at the FDA
• Cybersecurity (Updated)
• Job Opportunities at OSEL (Updated)
• Class I Recall: Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing (Updated)
• Video added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 4, 2021
• Video added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - August 11, 2021
• Federal Register: Guidance Documents Related to Coronavirus Disease 2019
• Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication
• Class I Recall:  Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks

October 4, 2021

• Consumer Information on:
  • RADIESSE (+) Lidocaine Injectable Implant - P050052/S129
  • Oncomine Dx Target Test - P160045/S028
  • Amplatzer Amulet Left Atrial Appendage Occluder - P200049
• Virtual Public Meeting - Orthopedic Strategically Coordinated Registry Network Meeting - November 4, 2021
• FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals - Guidance for Industry and Food and Drug Administration Staff
• De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff
• User Fees and Refunds for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff
• Acceptance Review for De Novo Classification Requests - Guidance for Industry and Food and Drug Administration Staff
• De Novo Classification Request (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190055 added)
• Federal Register: Medical Device De Novo Classification Process
• New Emergency Use Authorization
  • ACON Laboratories, Inc.

October 1, 2021

• MQSA National Statistics 
• Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication (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)