CDRHNew - News and Updates
March 1, 2021
- New Emergency Use Authorizations
- Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped
February 26, 2021
- Updated Emergency Use Authorizations
- 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
- 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
- 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
- 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
- Updated Emergency Use Authorizations
- 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
- 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
- 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
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- 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
- 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
- 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
- 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
February 10, 2021
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- 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
- 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
- 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
- Updated Emergency Use Authorizations
- 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
- 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
- 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
January 27, 2021
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- 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
- Updated Emergency Use Authorizations
- 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
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Accreditation Scheme for Conformity Assessment (ASCA) Annual Report Through 2020
January 22, 2021
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- 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)