CDRHNew - News and Updates

RSS News Feed for health professionals and consumers

RSS News Feed for regulated industry

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January 15, 2021

• Updated Emergency Use Authorizations
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Summary Minutes for November 6-7, 2019 General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting
• Transcripts for September 8-9, 2020 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting
• Summary Minutes for September 8-9, 2020 Orthopaedic and Rehabilitation 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)
• FAQs on Viral Transport Media During COVID-19 (Updated)

January 14, 2021

• New Emergency Use Authorizations
  • Ezplex SARS-CoV-2 G Kit (SML GENETREE Co., Ltd.)
• Re-issued Emergency Use Authorizations
  • BD Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson and Company (BD))
  • PerkinElmer New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
• Updated Emergency Use Authorizations
  • Sherlock CRISPR SARS-CoV-2 Kit (Sherlock BioSciences, Inc.)
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency - Guidance for Industry and Food and Drug Administration Staff
• 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)
• Summary Minutes for Nov. 14, 2019 Immunology Devices Panel Meeting
• Federal Register: Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices from Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program

January 13, 2021

• Updated Emergency Use Authorization
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Meeting Notice: February 17, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee
• Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 27, 2021
• Mammography: What You Need to Know (Updated)
• Breast Cancer Screening: Thermogram No Substitute for Mammogram (Updated)
• What to Know About Breast Implants (Updated)
• December 2020 PMA Approval List

January 12, 2021

• New Emergency Use Authorizations
  • RapCov Rapid COVID-19 Test (ADVAITE, Inc.)
  • EliA SARS-CoV-2-Sp1 IgG Test (Phadia AB)
  • VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho Clinical Diagnostics, Inc.)
• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 6, 2021
• Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
• FDA News Release: FDA Releases Artificial Intelligence/Machine Learning Action Plan
• 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)
• Federal Register: Meetings: Circulatory System Devices Panel of the Medical Devices Advisory Committee

January 11, 2021

• New Emergency Use Authorizations
  • Dimension EXL SARS‑CoV‑2 IgG (CV2G) (Siemens Healthcare Diagnostics Inc.)
  • Dimension Vista SARS‑CoV‑2 IgG (COV2G) (Siemens Healthcare Diagnostics Inc.)
• Updated Emergency Use Authorizations
  • Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay (Centers for Disease Control and Prevention (CDC))
  • Advanta Dx SARS-CoV-2 RT-PCR Assay (Fluidigm Corporation)
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Problems Reported with Essure (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 (Update)

January 8, 2021

• Re-issued Emergency Use Authorizations
  • Accula SARS-Cov-2 Test (Mesa Biotech Inc.)
  • Xpert Xpress SARS-CoV-2 test (Cepheid)
• Updated Emergency Use Authorizations
  • ExProbe SARS-CoV-2 Testing Kit (TBG Biotechnology Corp.)
  • OPTI SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
  • Genetrack SARS-CoV-2 Molecular Assay (Genetrack Biolabs, Inc.)
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• EUA Authorized Serology Test Performance (Updated)
• Consumer Information on: ActaStim-S Spine Fusion Stimulator - P190030
• Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers
• FDA News Release: FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)

January 7, 2021

• New Emergency Use Authorizations
  • Sterile Water for Humidifier (Vyaire Medical, Inc.)
• Updated Emergency Use Authorizations
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Accreditation Scheme for Conformity Assessment (ASCA) (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 (Update)
• Federal Register: Requests for Nominations: National Mammography Quality Assurance Advisory Committee

January 6, 2021

• New Emergency Use Authorizations
  • Simoa SARS-CoV-2 N Protein Antigen Test (Quanterix Corporation)
• Re-issued Emergency Use Authorizations
  • Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette (Salofa Oy)
  • OPTI SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
• Updated Emergency Use Authorizations
  • Primerdesign Ltd COVID-19 genesig Real-Time PCR assay (Primerdesign Ltd.)
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 13, 2021

January 5, 2021

• Safer Technologies Program for Medical Devices - Guidance for Industry and Food and Drug Administration Staff
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Guidance for Industry and Food and Drug Administration Staff
• Webinar - Safer Technologies Program: Final Guidance
• Safer Technologies Program (SteP) for Medical Devices
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Federal Register: Guidance: Safer Technologies Program for Medical Devices

January 4, 2021

• New Emergency Use Authorizations
  • MidaSpot COVID-19 Antibody Combo Detection Kit (Nirmidas Biotech, Inc.)
• Re-issued Emergency Use Authorizations
  • AMPIPROBE SARS-CoV-2 Test System (Enzo Life Sciences, Inc.)
• Updated Emergency Use Authorizations
  • Quick SARS-CoV-2rRT-PCR Kit (Zymo Research Corporation)
  • Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
• MQSA National Statistics
• Mouse Embryo Assay for Assisted Reproduction Technology Devices - Guidance for Industry and Food and Drug Administration Staff
• Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
• Federal Register: Guidance: Mouse Embryo Assay for Assisted Reproduction Technology Devices
• 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)

December 31, 2020

• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms

December 30, 2020

• Updated Emergency Use Authorizations
  • COVID-19 Coronavirus Real Time PCR Kit (Jiangsu Bioperfectus Technologies Co., Ltd.)
  • Biomeme SARS-CoV-2 Real-Time RT-PCR Test (Biomeme, Inc.)
  • Ellume COVID-19 Home Test (Ellume Limited)

December 29, 2020

• Product Labeling for Laparoscopic Power Morcellators - Guidance for Industry and Food and Drug Administration Staff
• UPDATE: Perform Only Contained Morcellation When Laparoscopic Power Morcellation Is Appropriate: FDA Safety Communication
• Laparoscopic Power Morcellators (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190035 and DEN200016 added)
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 6, 2021
• COVID-19 Tests and Collection Kits Authorized by the FDA in 2020: Infographic
• Center for Devices and Radiological Health's Response to Coronavirus (COVID-19): Infographic (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)
• Federal Register: Requests for Nominations: Technical Electronic Product Radiation Safety Standards Committee; Voting Members
• Federal Register: Guidance: Product Labeling for Laparoscopic Power Morcellators

December 28, 2020

• New Emergency Use Authorizations
  • Xpert Xpress SARS-CoV-2 DoD (Cepheid)
• Updated Emergency Use Authorizations
  • SARS-CoV-2 Fluorescent PCR Kit (Maccura Biotechnology (USA) LLC)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

December 23, 2020

• New Emergency Use Authorizations
  • Solana SARS-CoV-2 Assay (Quidel Corporation)
  • Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test (Quanterix Corporation)
• Updated Emergency Use Authorizations
  • Xpert Omni SARS-CoV-2 (Cepheid)
  • BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) (BioFire Diagnostics, LLC)
  • EmpowerDX At-Home COVID-19 PCR Test Kit (Clinical Enterprise, Inc.)
  • Ellume COVID-19 Home Test (Ellume Limited)
  • Alinity m SARS-CoV-2 assay (Abbott Molecular Inc.)
• Supplies of Medical Devices for COVID-19: Frequently Asked Questions
• Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
• Medical Device Types to Help Determine Section 506J Notification Obligations (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)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Class I Recall: Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device
• Consumer Information posted for MiniMed 770G System - P160017/S076

December 22, 2020

• Re-issued Emergency Use Authorizations
  • RightSign COVID-19 IgG/IgM Rapid Test Cassette (Hangzhou Biotest Biotech Co., Ltd.)
• Updated Emergency Use Authorizations
  • QuickVue SARS Antigen Test (Quidel Corporation)
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences)
  • TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
  • BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices - Questions and Answers (Revised) - Guidance for Industry and Food and Drug Administration Staff
• Presentation and Transcript posted for Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 16, 2020

December 21, 2020

• New Emergency Use Authorizations
  • QuickVue SARS Antigen Test (Quidel Corporation)
  • ADVIA Centaur IL6 assay (Siemens Healthcare Diagnostics Inc.)
  • SCONE
• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks

December 18, 2020

• New Emergency Use Authorizations
  • MatMaCorp COVID-19 2SF Test (Materials and Machines Corporation of America (DBA MatmaCorp, Inc.))
• Re-issued Emergency Use Authorizations
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences)
  • CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard)
  • TRUPCR SARS-CoV-2 Kit (3B Blackbio Biotech India Ltd., a subsidiary of Kilpest India Ltd.)
• Updated Emergency Use Authorizations
  • BioCore 2019-nCoV Real Time PCR Kit (BioCore Co., Ltd.)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200035 added)
• 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)
• Federal Register: Request for Nominations: National Mammography Quality Assurance Advisory Committee

December 17, 2020

• New Emergency Use Authorizations
  • Aptima SARS-CoV-2/Flu assay (Hologic, Inc.)
  • Procedure Mask with Earloops (Honeywell International Inc.)
• Re-issued Emergency Use Authorizations
  • SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
• Updated Emergency Use Authorizations
  • Ellume COVID-19 Home Test (Ellume Limited)
• Presentation and Transcript posted for Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - December 8, 2020
• Presentation and Transcript posted for Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 9, 2020
• Consumer Information on: FoundationOne Liquid CDx - P200016
• 4th Q FY2020 MDUFA IV Performance Report
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

December 16, 2020

• New Emergency Use Authorizations
  • GENETWORx Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
  • PacificDx Covid-19 Test (ResearchDx, Inc., DBA Pacific Diagnostics)
  • ACON SARS-CoV-2 IgG/IgM Rapid Test (ACON Laboratories, Inc.)
  • BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
• Re-issued Emergency Authorizations
  • Phosphorus COVID-19 RT-qPCR Test (Phosphorus Diagnostics LLC)
• Updated Emergency Use Authorizations
  • cobas SARS-CoV-2 & Influenza A/B (Roche Molecular Systems, Inc.)
• News Release: Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test
• 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)

December 15, 2020

• New Emergency Use Authorizations
  • Ellume COVID-19 Home Test (Ellume Limited)
• Non-In Vitro Diagnostic eSTAR (Updated)
• In Vitro Diagnostic eSTAR (Updated)
• Consumer Information on: Plasma Delipidation System (PDS-2™ System) – H190001
• Consumer Information on: Sonalleve MR-HIFU – H190003
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers
• News Release: Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

December 14, 2020

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Imported, Non-NIOSH Approved Respirators Manufactured in China
• 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)

December 11, 2020

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks
  • cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System (Roche Molecular Systems, Inc.)
  • DxTerity SARS-CoV-2 RT-PCR Test (DxTerity Diagnostics, Inc.)
• 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)