CDRHNew - News and Updates

December 6, 2021

• Reissued Emergency Use Authorizations
  • iHealth COVID-19 Antigen Rapid Test (iHealth Labs, Inc.)
• Revised Emergency Use Authorizations
  • CareStart COVID-19 Antigen test (Access Bio, Inc.)
• Updated Emergency Use Authorizations
  • GWU SARS-CoV-2 RT-PCR Test (George Washington University Public Health Laboratory)
  • CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)
• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
• Transcript for Orthopedic Strategically Coordinated Registry Network Meeting - 11/04/2021

December 3, 2021

• Class I Recall: Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation
• EUA Authorized Serology Test Performance (Updated)
• SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

December 2, 2021

• Consumer Information on: Portico Transcatheter Aortic Valve Implantation System - P190023
• Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease
• August 7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality (Updated)
• Federal Register: Request for Nominations: National Mammography Quality Assurance Advisory Committee
• Federal Register: Request for Nominations: National Mammography Quality Assurance Advisory Committee

December 1, 2021

• New Emergency Use Authorizations
  • HealthPulse@home (Audere)
• Re-Issued Emergency Use Authorizations
  • LumiraDx SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
  • Kwokman Diagnostics COVID-19 Home Collection Kit (Kwokman Diagnostics, LLC)
• Updated Emergency Use Authorizations
  • Aptima SARS-CoV-2/Flu assay (Hologic, Inc.)
  • MD Anderson High-throughput SARS-CoV-2 RT-PCR Assay (University of Texas MD Anderson Cancer Center, Molecular Diagnostics Laboratory)
  • CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)
• UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care Providers
• List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
• Reclassification (Updated)
• MQSA National Statistics as of December 1, 2021
• Federal Register: Anesthesiology Devices; Classification of the Isocapnic Ventilation Device
• Federal Register: Gastroenterology-Urology Devices; Classification of the Esophageal Tissue Characterization System
• Federal Register: Neurological Devices; Classification of the Conditioning Tool for Eating Disorders
• Federal Register: Neurological Devices; Classification of the Trunk and Limb Electrical Stimulator to Treat Headache
• Federal Register: Orthopedic Devices; Classification of the Intraoperative Orthopedic Strain Sensor

November 30, 2021

• Cybersecurity (Updated)
• Federal Register: Charter Renewal: Patient Engagement Advisory Committee

November 29, 2021

• Transcript for October 20, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
• Premarket Submissions: Selecting and Preparing the Correct Submission (Updated)
• Voluntary eSTAR Program
• Federal Register: Requests for Nominations: Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee

November 26, 2021

• Transcript added to Virtual Public Workshop - Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices - October 14, 2021

November 24, 2021

• Webinar - De Novo Classification Process and FDA and Industry Actions: Effect on FDA Review Clock and Goals, Final Guidances - December 14, 2021

November 23, 2021

• Reissued Emergency Use Authorizations
  • Abbott RealTime SARS-CoV-2 assay (Abbott Molecular)
• Updated Emergency Use Authorizations
  • MiraDx SARS-CoV-2 RT-PCR assay (MiraDx)
  • Aeon Global Health SARS-CoV-2 Assay (Aeon Global Health)
  • BD Veritor At-Home COVID-19 Test (Becton, Dickinson and Company (BD))
• Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)

November 22, 2021

• New Emergency Use Authorizations
  • SCoV-2 Ag Detect Rapid Self-Test (InBios International Inc.)
• Reissused Emergency Use Authorizations
  • COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (Healgen Scientific LLC)
  • GenBody COVID-19 Ag (GenBody Inc.)
  • INDICAID COVID-19 Rapid Antigen Test (PHASE Scientific International, Ltd.)
  • BD Veritor At-Home COVID-19 Test (Becton, Dickinson and Company (BD))
• Revised Emergency Use Authorizations
  • GENETWORx Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
  • SGTi-flex COVID-19 IgG (Sugentech, Inc.)
  • VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho Clinical Diagnostics, Inc.)
• Updated Emergency Use Authorizations
  • Personal Protective Equipment EUAs (Update to Appendix A)
  • CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)
• Federal Register: General and Plastic Surgery Devices; Classification of the General Laparoscopic Power Morcellation Containment System

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
  • 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.)