CDRHNew - News and Updates

March 1, 2021

• New Emergency Use Authorizations
  • QuickVue At-Home COVID-19 Test (Quidel Corporation)
  • covidSHIELD (University of Illinois Office of the Vice President for Economic Development and Innovation)
• Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped

February 26, 2021

• Updated Emergency Use Authorizations
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Consumer Information on: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter - P200039
• Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

February 25, 2021

• Updated Emergency Use Authorizations
  • Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 3, 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)

February 24, 2021

• Updated Emergency Use Authorizations
  • Appendix B: Authorized Ventilator Accessories
• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 17, 2021

February 23, 2021

• Updated Emergency Use Authorizations
  • DxTerity SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.) 
  • SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • BD Veritor System for Rapid Detection of SARS-CoV-2 (Becton, Dickinson and Company (BD))
  • Appendix B: Authorized Ventilators
• 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: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Humanitarian Use Devices

February 22, 2021

• Reissued Emergency Use Authorizations
  • Color COVID-19 Self-Swab Collection Kit (Color Genomics, Inc.)
  • LetsGetChecked Coronavirus (COVID-19) Test (PrivaPath Diagnostics, Inc.)
• Updated Emergency Use Authorizations
  • Kroger Health COVID-19 Test Home Collection Kit (The Kroger Co.)
  • Everlywell COVID-19 Test Home Collection Kit DTC (Everlywell, Inc.)
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests - Guidance for Test Developers and Food and Drug Administration Staff
• Catalog of Regulatory Science Tools to Help Assess New Medical Devices (Updated)
• Class I Recall: Hillrom Recalls Liko Multirall 200 Overhead Lift Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals:Shortages Data Collections
• 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)
• 13th Annual FDA/AdvaMed Medical Devices Statistical Issues Conference - May 10-12, 2021

February 19, 2021

• Updated Emergency Use Authorizations
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Pulse Oximeter Accuracy and Limitations: FDA Safety Communication
• Class I Recall: Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit
• 24 Hour Summary and Presentations for February 17, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting

February 18, 2021

• Updated Emergency Use Authorizations
  • Appendix A: Authorized Respirators, Non-NIOSH Respirators Manufactured in China
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 24, 2021
• Listing of CDRH Humanitarian Device Exemptions (Added H200001)
• Dental Amalgam Fillings Recommendations - Graphics
• Medical Device Shortages During the COVID-19 Public Health Emergency (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)
• Federal Register: Meetings: Medical Device User Fee Amendments of Fiscal Years 2023 to 2027 Reauthorization

February 17, 2021

• New Emergency Use Authorizations
  • Gravity Diagnostics SARS-CoV-2 RT-PCR for use with DTC kits (Gravity Diagnostics, LLC)
  • Assurance SARS-CoV-2 Panel DTC (Assurance Scientific Laboratories)
  • Everlywell COVID-19 Test Home Collection Kit DTC (Everlywell, Inc.)
• Reissued Emergency Use Authorizations
  • Kroger Health COVID-19 Test Home Collection Kit (Kroger Co.)
• Updated Emergency Use Authorizations
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic - February 23, 2021
• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 10, 2021
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• FAQs on Viral Transport Media During COVID-19 (Updated)
• Federal Register: Charter Renewal: Technical Electronic Product Radiation Safety Standards Committee

February 16, 2021

• New Emergency Use Authorizations
  • Visby Medical COVID-19 Point of Care Test (Visby Medical, Inc.)
  • Bio-Rad Reliance SARS-CoV-2/FluA/FluB RT-PCR Assay Kit (Bio-Rad Laboratories, Inc)
  • BD SARS-CoV-2/Flu for BD MAX System (Becton, Dickinson and Company (BD))
  • TaqPath COVID-19, FluA, FluB Combo Kit (Thermo Fisher Scientific)
  • Procleix SARS-CoV-2 Assay (Grifols Diagnostic Solutions Inc.)
  • IDS SARS-CoV-2 IgG (Immunodiagnostic Systems Ltd.)
• Reissued Emergency Use Authorization
  • DxTerity SARS-CoV-2 RT PCR CE Test (DxTerity Diagnostics, Inc.)
  • LumiraDx SARS-CoV-2 RNA STAR Complete (LumiraDx UK Ltd.)
  • VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack (Ortho-Clinical Diagnostics, Inc.)
• Updated Emergency Use Authorizations
  • GENETWORx Covid-19 Nasal Swab Test (RCA Laboratory Services LLC dba GENETWORx)
  • CareStart COVID-19 MDx RT-PCR (Access Bio, Inc.)
  • U-TOP COVID-19 Detection Kit (SEASUN BIOMATERIALS)
  • Ellume COVID-19 Home Test (Ellume Limited)
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Revoked Emergency Use Authorizations
  • Nova2200 for Decontaminating Compatible N95 Respirators
• Meeting Notice: March 23, 2021 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
• FDA Voices: Reflections on a Record Year for Novel Device Innovation Despite COVID-19 Challenges
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
• Consumer Information on: Imagio® Breast Imaging System - P200003

February 12, 2021

• Updated Emergency Use Authorizations
  • Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
• Meeting Materials for February 17, 2021 Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting
• MDUFA Reports
• Federal Register: Meetings: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
• Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Device Tracking

February 11, 2021

• Updated Emergency Use Authorizations
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)

February 10, 2021

• Reissued Emergency Use Authorizations
  • VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack (Ortho Clinical Diagnostics, Inc.)
• Updated Emergency Use Authorizations
  • Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
• Accreditation Scheme for Conformity Assessment (ASCA) (Updated)
• Consumer Information on: DiamondTemp Ablation Catheters - P200028
• Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)

February 9, 2021

• Reissued Emergency Use Authorizations
  • PerkinElmer New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
• Updated Emergency Use Authorizations
  • SalivaDirect (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
  • QDX SARS-CoV-2 Assay (QDx Pathology Services)
  • MidaSpot COVID-19 Antibody Combo Detection Kit (Nirmidas Biotech, Inc.)
  • CareStart COVID-19 Antigen test (Access Bio, Inc.)
  • Appendix B: Authorized Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers
• Cochlear Implants and MRI Safety
• Listing of CDRH Humanitarian Device Exemptions (Updated)
• MedSun Newsletter, February 2021

February 8, 2021

• Updated Emergency Use Authorizations
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• 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 (DEN200018 added)
• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 3, 2021

February 5, 2021

• New Emergency Use Authorizations
  • BD MAX COVID-19 ASSAY (Authorized by HHS/OASH) (Hospital of the University of Pennsylvania)
  • PMSF-INNO SARS-CoV-2 RT-PCR Test (Authorized by HHS/OASH) (INNO Diagnostics Reference Laboratory, Ponce Medical School)
  • Clinomics TrioDx RT-PCR COVID-19 Test (Clinomics USA Inc.)
  • Status COVID-19/Flu (Princeton BioMeditech Corp.)
• Updated Emergency Use Authorizations
  • IntelliPlex SARS-CoV-2 Detection Kit (PlexBio Co., Ltd.)
  • Accula SARS-Cov-2 Test (Mesa Biotech Inc.)
  • Lyra SARS-CoV-2 Assay (Quidel Corporation)
  • QuantiVirus SARS-CoV-2 Test kit (DiaCarta, Inc)
  • CareStart COVID-19 MDx RT-PCR (Access Bio, Inc.)
  • Cormeum SARS-CoV-2 Assay (Cormeum Laboratory Services)
  • Appendix A: Authorized Surgical Masks and Surgical Masks Removed from Appendix A
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Presentation and Transcript posted for Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators during the COVID-19 Pandemic - January 26, 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)

February 4, 2021

• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 10, 2021
• Consumer Information on: Revanesse® Lips+ - P160042/S010
• 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)
• Consumer Information on: Gore® Excluder® Conformable AAA Endoprosthesis - P200030
• Consumer Information on: Clareon Aspheric IOL, Clareon Toric Aspheric IOL, Clareon Aspheric IOL, AutonoMe System, Clareon Toric IOL, AutonoMe System - P190018
• Consumer Information on: Osseonachored Prostheses for Rehabiliation of Amputees (OPRA)TM Implant System - P190009

February 3, 2021

• Reissued Emergency Use Authorizations
  • CareStart COVID-19 Antigen test (Access Bio, Inc.)
• Updated Emergency Use Authorizations
  • Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGI Genomics Co. Ltd)
• January 2021 PMA Approval List
• Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
• Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 27, 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)

February 2, 2021

• Updated Emergency Use Authorizations
  • Appendix B: Authorized Ventilator Accessories
• CDRH Patient Science and Engagement Program
• 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)
• Class I Recall: Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures

February 1, 2021

• Updated Emergency Use Authorizations
  • VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack (Ortho Clinical Diagnostics, Inc.)
  • DSL COVID-19 Assay (Diagnostic Solutions Laboratory, LLC)
  • OPTI SARS-CoV-2 RT PCR Test (OPTI Medical Systems, Inc.)
  • SNL-NM 2019 nCoV Real-Time RT-PCR Diagnostic Assay (Sandia National Laboratories)
  • CSI SARS-CoV-2 RT PCR Test (CSI Laboratories)
  • Appendix A: Authorized Surgical Masks
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• Consumer Information on: Restylane® Kysse - P140029/S021
• MQSA National Statistics
• FAQs on Viral Transport Media During COVID-19 (Updated)

January 29, 2021

• Reissued Emergency Use Authorizations
  • Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (BGI Genomics Co. Ltd)
• Updated Emergency Use Authorizations
  • Xpert Xpress SARS-CoV-2/Flu/RSV (Cepheid)
  • MassARRAY SARS-CoV-2 Panel (Agena Bioscience, Inc.)
  • BayCare SARS-CoV-2 RT PCR Assay (BayCare Laboratories, LLC)
  • Alpha Genomix TaqPath SARS-CoV-2 Combo Assay (Alpha Genomix Laboratories)
  • SARS-CoV-2 Assay (AIT Laboratories)
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• February 2021 Dates Announced for the Virtual Town Hall Series for Test Developers on Coronavirus (COVID-19)
• Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage
• 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)

January 28, 2021

• Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) - Guidance for Industry and Food and Drug Administration Staff

January 27, 2021

• Reissued Emergency Use Authorizations
  • FTD SARS-CoV-2 (Fast Track Diagnostics Luxembourg S.á.r.l. (A Siemens Healthineers Company))
• Updated Emergency Use Authorizations
  • Lyra Direct SARS-CoV-2 Assay (Quidel Corporation)
  • NeoPlex COVID-19 Detection Kit (GeneMatrix, Inc.)
  • LumiraDx SARS-CoV-2 Ag Test (LumiraDx UK Ltd.)
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 3, 2021
• Consumer Information on: Vercise™ PC and Vercise Gevia™ Deep Brain Stimulation (DBS) System - P150031/S028
• 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)

January 26, 2021

• New Emergency Use Authorizations
  • Sovereign America Surgical Mask, Model #: 2000SM1, Blue Color
• Updated Emergency Use Authorizations
  • MidaSpot COVID-19 Antibody Combo Detection Kit - Nirmidas Biotech, Inc.
• Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic (Updated)
• Summary Minutes for October 22, 2020 Patient Engagement Advisory Committee Meeting

January 25, 2021

• New Emergency Use Authorizations
  • Procedure Mask with Earloops, Model #: 559250M D (Honeywell International Inc.)
  • Ambry COVID-19 RT-PCR Test (Ambry Genetics Laboratory)
• Reissued Emergency Use Authorizations
  • Express Gene 2019-nCoV RT-PCR Diagnostic Panel (Express Gene LLC, DBA: Express Gene Molecular Diagnostics Laboratory)
  • NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.)
• Updated Emergency Use Authorizations
  • Panther Fusion SARS-CoV-2 Assay (Hologic, Inc.)
  • Aptima SARS-CoV-2 assay (Hologic, Inc.)
• Accreditation Scheme for Conformity Assessment (ASCA) Annual Report Through 2020

January 22, 2021

• New Emergency Use Authorizations
  • F2001N Respirator (Macopharma)
• Reissued Emergency Use Authorizations
  • Decontamination Systems for Personal Protective Equipment EUAs (Updated)
• Updated Emergency Use Authorizations
  • Exhibit 1: Authorized Imported, Non-NIOSH Disposable Filtering Facepiece Respirators (FFR)
• FAQs for Filtering Facepiece Respirator (FFR) Decontamination Systems
• PPE Webinar Use of Dry Heat to Support Single-User Reuse of Certain Respirators - January 26, 2021
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 27, 2021
• Webinar - Safer Technologies Program: Final Guidance - February 1, 2021
• Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 3, 10, 17, and 24, 2021
• Third Party Review Organization Performance Report for FY2021 Q1
• Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)