CDRHNew - News and Updates

May 7, 2021

• New Emergency Use Authorizations
  • SCoV-2 Ag Detect Rapid Test (InBios International, Inc.)
• Re-issued Emergency Use Authorizations
  • Clarifi COVID-19 Test Kit (Quadrant Biosciences Inc.)
• Updated Emergency Use Authorizations
  • BioFire COVID-19 Test (BioFire Defense, LLC)
  • SalivaDirect At-Home Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • Aptima SARS-CoV-2/Flu assay (Hologic, Inc.)
  • Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit (Bio-Rad Laboratories, Inc.)
  • Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.)
  • Appendix A: Authorized Surgical Masks

May 6, 2021

• New Emergency Use Authorizations
  • Negative Pressure SteriDome (NPS)
• Transcript and Summary Minutes for April 6, 2021 Circulatory Devices Panel of the Medical Devices Advisory Committee Meeting
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms

May 5, 2021

• Re-issued Emergency Use Authorizations
  • Ambry COVID-19 RT-PCR Test (Ambry Genetics Laboratory)
• Updated Emergency Use Authorizations
  • Ezplex SARS-CoV-2 G Kit (SML GENETREE Co., Ltd.)
  • MassARRAY SARS-CoV-2 Panel (Agena Bioscience, Inc.)
  • Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.)
• Webinar - ASCA Pilot: Streamlining Conformity Assessment in Device Submissions - May 20, 2021
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200019 added)
• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 28, 2021
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 12, 2021
• Consumer Information on: Medtronic Harmony Transcatheter Pulmonary Valve (TPV) System - P200046
• Transcript for March 23, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

May 4, 2021

• New Emergency Use Authorizations
  • ISOCUBE One and ISOCUBE SS (Prep Tech LLC)
• Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Medical Device Types to Help Determine Section 506J Notification Obligations (Update)

May 3, 2021

• Information about Automated Endoscope Reprocessors (AERs) and FDA's Evaluation (Updated)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

April 30, 2021

• Updated Emergency Use Authorizations
  • BD SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company (BD))
  • BD SARS-CoV-2/Flu for BD MAX System (Becton, Dickinson and Company (BD))
  • Genetrack SARS-CoV-2 Molecular Assay (Genetrack Biolabs, Inc.)
  • DxTerity SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)
  • AQ-TOP COVID-19 Rapid Detection Kit PLUS (SEASUN BIOMATERIALS, Inc.)
• Revised Emergency Use Authorizations
  • BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ) (BioFire Diagnostics, LLC)
  • RapCov Rapid COVID-19 Test (ADVAITE, Inc.)
  • MosaiQ COVID-19 Antibody Magazine (Quotient Suisse SA)
  • SARS-CoV-2 IgG assay (Abbott Laboratories Inc.)
• Re-issued Emergency Use Authorizations
  • COVID-19 RT-PCR Test (Laboratory Corporation of America (LabCorp))
• Revoked Emergency Use Authorizations
  • Battelle Decontamination System
• Class I Recall: Pacific Medical Group (DBA Avante Health Solutions) Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• MQSA Inspection Billing Invoice Process Going Electronic

April 29, 2021

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks
• Consumer Resources (Updated)
• Virtual Public Workshop - Orthopedic Device Postmarket Review - June 10, 2021
• Sharps Disposal Containers in Health Care Facilities
• 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)

April 28, 2021

• Updated Emergency Use Authorizations
  • Appendix B: Authorized Ventilator Accessories
• EUA Authorized Serology Test Performance (Updated)
• Medical Device User Fee Amendments (MDUFA) (Updated)
• ASCA-Accredited Testing Laboratories (Updated)
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - May 5, 2021
• Federal Register: Medical Device Reporting
• Federal Register: Modifications to the List of Recognized Standards, Recognition List Numbers: 055

April 27, 2021

• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 21, 2021
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

April 26, 2021

• Re-issued Emergency Use Authorizations
  • BD SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company (BD))
  • Illumina COVIDSeq Test (Illumina, Inc.)
  • Rapid COVID-19 IgM/IgG Combo Test Kit (Megna Health, Inc.)
  • SGTi-flex COVID-19 IgG (Sugentech, Inc.)
• Updated Emergency Use Authorizations
  • NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay (NeuMoDx Molecular, Inc.)
  • EURORealTime SARS-Cov-2 (Euroimmun US, Inc.)
  • CareStart COVID-19 IgM/IgG (Access Bio, Inc.)
• 510(k) Program Pilots (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)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200046 added)

April 23, 2021

• Cordis Recalls Precise PRO Rx US Carotid System Due to Risk of Separation in Device During Use
• FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic (Updated)
• Importing Medical Devices During the COVID-19 Pandemic (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)

April 22, 2021

• New Emergency Use Authorizations
  • Kaiser Permanente High Throughput SARS-CoV-2 Assay (Southern California Permanente Medical Group)
  • DetectX-Rv (PathogenDx, Inc.)
  • QUANTA Flash SARS-CoV-2 IgG (Inova Diagnostics, Inc.)
• Re-issued Emergency Use Authorizations
  • OPTI SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
  • Xpert Omni SARS-CoV-2 (Cepheid)
• Updated Emergency Use Authorizations
  • Lyra SARS-CoV-2 Assay (Quidel Corporation)
  • BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
• Federal Register: Authorization of Emergency Use of Certain Medical Devices During COVID-19

April 21, 2021

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks
• Presentations and Transcripts added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - December 2, 2020 and April 14, 2021
• New CDRH Learn Modules: How to Use Consensus Standards in Premarket Submissions and The ASCA Pilot: Streamlining Conformity Assessment in Device Submissions
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 28, 2021

April 20, 2021

• New Emergency Use Authorizations
  • Pooling and Serial Testing Amendment for Certain Molecular Diagnostic Tests for SARS-CoV-2
• Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop
• Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - April 27, 2021

April 19, 2021

• New Emergency Use Authorizations
  • SynergyDx SARS-CoV-2 RNA Test DTC (Synergy Diagnostic Laboratory, Inc., DBA SynergyDx)
  • SynergyDx SARS-CoV-2 RNA Test (Synergy Diagnostic Laboratory, Inc., DBA SynergyDx)
  • Celltrion DiaTrust COVID-19 Ag Rapid Test (Celltrion USA, Inc.)
  • Healthcare Pro Surgical Masks (BLUETRACK, Inc.)
  • 3 Ply Surgical Mask (Manohar Filaments Private Limited)
• Reissued Emergency Use Authorizations
  • Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 (STS Lab Holdco (a subsidiary of Amazon.com Services LLC))
• Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Posts
• FDA-Industry MDUFA V Reauthotization Meeting, March 17, 2021
• Summary Minutes for October 27, 2020 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
• Consumer Information on: Simplify® Cervical Artificial Disc – P200022/S003

April 16, 2021

• New Emergency Use Authorizations
  • Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test (LGC, Biosearch Technologies)
• Reissued Emergency Use Authorizations
  • LumiraDx SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
• Updated Emergency Use Authorizations
  • Allplex 2019-nCoV Assay (Seegene, Inc.)
  • Color COVID-19 Self-Swab Collection Kit with Saline (Color Health, Inc.)
  • CareStart COVID-19 Antigen test (Access Bio, Inc.)
• Revised Emergency Use Authorizations
  • Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test (Quanterix Corporation)
• The FDA issues final rule amending medical device classification regulations, excluding non-device software functions
• Class I Recall: CareFusion 303, Inc. Recalls BD Alaris Pump Module Model 8100 Due to Risk of Stuck or Unresponsive Keys
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Federal Register: Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures Act

April 15, 2021

• New Emergency Use Authorizations
  • SalivaDirect At-Home Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • Color COVID-19 Self-Swab Collection Kit with Saline (Color Health, Inc.)
• Reissued Emergency Use Authorizations
  • Color SARS-CoV-2 RT-LAMP Diagnostic Assay (Color Health, Inc.)
  • BD Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson and Company (BD))
• Updated Emergency Use Authorizations
  • Gravity Diagnostics SARS-CoV-2 RT-PCR Assay (Gravity Diagnostics, LLC)
  • Fulgent COVID-19 by RT-PCR Test (Fulgent Therapeutics)
  • BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
  • COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc)
• Federal Register: Medical Devices: Class I Surgeon's and Patient Examination Gloves
• Federal Register: Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices from Premarket Notification Requirements; Withdrawal of Proposed Exemptions
• New CDRH Learn Module - MDSAP: Production and Service Controls Process: Part 3
• Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)
• Class I Recall: Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports

April 14, 2021

• New Emergency Use Authorizations
  • Clinical Enterprise SARS-CoV-2 RT-PCR Assay (Clinical Enterprise, Inc.)
  • Clinical Enterprise SARS-CoV-2 RT-PCR Assay DTC (Clinical Enterprise, Inc.)
  • Omnia SARS-CoV-2 Antigen Test (Qorvo Biotechnologies, LLC.)
• Updated Emergency Use Authorizations
  • cobas SARS-CoV-2 (Roche Molecular Systems, Inc. (RMS))
  • BD SARS-CoV-2/Flu for BD MAX System (Becton, Dickinson and Company (BD))
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 21, 2021
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)

April 13, 2021

• New Emergency Use Authorizations
  • Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit (Thermo Fisher Scientific)
  • PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit (PerkinElmer Genomics)
  • Airborne Isolation Hood Device
• Reissued Emergency Use Authorizations
  • cobas SARS-CoV-2 (Roche Molecular Systems, Inc. (RMS))
  • Fulgent COVID-19 by RT-PCR Test (Fulgent Therapeutics LLC)
  • CareStart COVID-19 Antigen test (Access Bio, Inc.)
  • BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
• Updated Emergency Use Authorization
  • MidaSpot COVID-19 Antibody Combo Detection Kit (Nirmidas Biotech, Inc.)
• New CDRH Learn Module - MDSAP: Production and Service Controls Process: Part 2
• 24 Hour Summary for April 6, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200055 added)

April 12, 2021

• New Emergency Use Authorizations
  • Lucira CHECK-IT COVID-19 Test Kit (Lucira Health, Inc.)
• Re-issued Emergency Use Authorizations
  • SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
• Updated Emergency Use Authorizations
  • BD SARS-CoV-2/Flu for BD MAX System (Becton, Dickinson and Company (BD))
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences)
• ASCA-Accredited Testing Laboratories
• Class I Recall: Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery Life
• Class I Recall: Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum
• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 7, 2021
• Problems Reported with Essure (Updated)
• Consumer Information on: ClearVisc Ophthalmic Viscosurgical Device – P200025
• Consumer Information on: AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) – P190013
• Consumer Information on: Exablate Model 4000 System - Type 1.0 and 1.1 (Exablate Neuro) P150038/S006
• Removal Lists of Tests that Should No Longer Be Used and/or Distributed for COVID-19: FAQs on Testing for SARS-CoV-2 (Updated)

April 9, 2021

• FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities
• New CDRH Learn Module - MDSAP: Production and Service Controls Process, Part 1
• Class I Recall: Medtronic Recalls Valiant Navion Thoracic Stent Graft System Due to Risk of Stent Fractures and Type III Endoleaks
• Training Curriculum for Third-Party Reviewers
• 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)
• MedSun Newsletter - April 2021 

April 8, 2021

• New CDRH Learn Module - MDSAP: Design and Development Process
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200038 added)

April 7, 2021

• New Emergency Use Authorizations
  • SARS-CoV-2 real time RT-PCR test (Authorized by HHS/OASH) (University of Louisville Infectious Diseases Laboratory)
• Updated Emergency Use Authorizations
  • PhoenixDx SARS-CoV-2 Multiplex (Trax Management Services Inc.)
  • FTD SARS-CoV-2 (Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company))
  • SARS-CoV-2 Test (Biocerna)
  • BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 31, 2021
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - April 14, 2021
• FAQs on Viral Transport Media During COVID-19 (Updated)

April 6, 2021

• New Emergency Use Authorizations
  • COVID-19 Self-Collected Antibody Test System (Symbiotica, Inc.)
• Updated Emergency Use Authorizations
  • Appendix A: Authorized Surgical Masks
• Consumer Information on: TheraSphere™ - P200029
• New CDRH Learn Modules - MDSAP: Measurement, Analysis and Improvement Process and MDSAP: Medical Device Adverse Events and Advisory Notices Reporting
• FAQs on Viral Transport Media During COVID-19 (Updated)

April 5, 2021

• Re-issued Emergency Use Authorizations
  • covidSHIELD (University of Illinois Office of the Vice President for Economic Development and Innovation)
  • Verily COVID-19 RT-PCR Test (Verily Life Sciences)
  • Alimetrix SARS-CoV-2 RT-PCR Assay (Alimetrix, Inc.)
• Updated 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.)
• 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)