CDRHNew - News and Updates
March 2, 2022
- Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System - 03/16/2022 (Updated Agenda)
- Scientific Fellowships at CDRH (Updated)
- Consumer Information on: Eversense E3 Continuous Glucose Monitoring System - P160048/S016
- Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication (Updated)
March 1, 2022
- Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders - Guidance for Mammography Facilities and Food and Drug Administration Staff
- Center for Devices and Radiological Health (CDRH) Appeals Processes - Guidance for Industry and Food and Drug Administration Staff
- Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication
- Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication
- Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication
- MQSA National Statistics (Updated)
- Federal Register: Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, etc.
February 28, 2022
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170070 added)
- Meeting materials posted: March 2, 2022 Device Good Manufacturing Practice Advisory Committee
- FDA Advisory Panel Recommendations on Lifelong Surveillance and Long-Term Postmarket Data Collection for Patients with AAA Endovascular Aortic Repair – Letter to Health Care Providers
- Federal Register: Orthopedic Devices; Classification of the Screw Sleeve Bone Fixation Device
February 25, 2022
- Revised Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Assurance SARS-CoV-2 Panel (Assurance Scientific Laboratories)
- Assurance SARS-CoV-2 Panel DTC (Assurance Scientific Laboratories)
- SalivaDirect for use with DTC Kits (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
- SalivaDirect DTC Saliva Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
- 1st Q FY 2022 MDUFA IV Performance Report
February 24, 2022
- Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers (Updated)
- COVID-19 Test Development and Review: FAQs on Testing for SARS-CoV-2 (Updated)
- COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2 (Updated)
February 23, 2022
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 9, 2022
- Class I and Class II Device Exemptions
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210034 added)
- Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use
February 22, 2022
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- BD SARS-CoV-2 Reagents for BD MAX System (Becton, Dickinson and Company (BD))
- Revised Emergency Use Authorizations
- Scientific Fellowships at CDRH (Updated)
- Quality System (QS) Regulation/Medical Device Good Manufacturing Practices (Updated)
- Proposed Rule: Quality System Regulation Amendments – Frequently Asked Questions
- At-Home OTC COVID-19 Diagnostic Tests
- Federal Register: Proposed Rule: Medical Devices: Quality System Regulation
February 18, 2022
- E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
- BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give False Results, and Require Special Training for Safe Handling
- Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication (Updated)
- About Manufacturer and User Facility Device Experience (MAUDE) (Updated)
- MDR Data Files (Updated)
- Medical Device Reporting (MDR): How to Report Medical Device Problems (Updated)
- Jobs at the Center for Devices and Radiological Health (CDRH) (Updated)
February 17, 2022
- Meeting Announcement: March 2, 2022 Device Good Manufacturing Practice Advisory Committee
- Class I Recall: Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations
- Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System - March 16-17, 2022
- Federal Register: Cardiovascular Devices; Classification of the Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access
- Federal Register: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Integrated Continuous Glucose Monitoring System
- Federal Register: Ophthalmic Devices; Classification of the Electromechanical Tear Stimulator
- Federal Register: Center for Devices and Radiological Health Appeals Processes
February 16, 2022
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Revoked Emergency Use Authorization
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 23, 2022
- Federal Register: Device Good Manufacturing Practice Advisory Committee
February 15, 2022
- Consumer Information on: Senza Spinal Cord Stimulation (SCS) System – P130022/S042
- Federal Register: Technical Electronic Product Radiation Safety Standards Committee
February 14, 2022
- Updated Emergency Use Authorizations
- Tracking Your Premarket Submission's Progress (Progress Tracker) (Updated)
- FDA Activities Related to Essure (Updated)
- Information for Patients and Health Care Providers: Essure (Updated)
February 11, 2022
- FAQs on Viral Transport Media During COVID-19 (Updated)
- ASCA-Accredited Testing Laboratories (Updated)
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - January 26, 2022
- Federal Register: Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator
- Federal Register: General Hospital and Personal Use Devices; Classification of the Spore Test Strip
February 10, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics, Inc.)
- Anti-SARS-CoV-2 ELISA (IgG) (EUROIMMUN US Inc.)
- Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue Health Inc.)
- Appendix A: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2 - Removal of SARS-CoV-2 Test (Biocerna)
- Revised Emergency Use Authorizations
- Revoked Emergency Use Authorization
February 8, 2022
- January 2022 PMA Approval List
- Potential Risk of Strangulation in Children Who Use Enteral Feeding Delivery Sets - FDA Safety Communication
February 7, 2022
- New Emergecy Use Authorization
- Reissued Emergency Use Authorizations
- BinaxNOW COVID-19 Ag Card Home Test (Abbott Diagnostics Scarborough, Inc.)
- BinaxNOW COVID-19 Ag 2 Card (Abbott Diagnostics Scarborough, Inc.)
- ADEXUSDx COVID-19 Test (NOWDiagnostics, Inc.)
- LetsGetChecked Coronavirus (COVID-19) (LetsGetChecked, Inc.)
- PMLS SARS-CoV-2 Assay (Premier Medical Laboratory Services)
- Revised Emergency Use Authorizations
- BinaxNOW COVID-19 Ag Card (Abbott Diagnostics Scarborough, Inc.)
- Nano-Check COVID-19 Antigen Test (Nano-Ditech Corp.)
- Assure COVID-19 IgG/IgM Rapid Test Device (Assure Tech. (Hangzhou Co., Ltd))
- cPass SARS-CoV-2 Neutralization Antibody Detection Kit (GenScript USA Inc.)
- PerkinElmer New Coronavirus Nucleic Acid Detection Kit (PerkinElmer, Inc.)
- Advanta Dx SARS-CoV-2 RT-PCR Assay (Fluidigm Corporation)
- Color COVID-19 Self-Swab Collection Kit with Saline (Color Health, Inc.)
- Updated Emergency Use Authorization
- Federal Register: Establishment Registration and Device Listing for Manufacturers and Importers of Devices
February 4, 2022
- Consumer Information on: Nucleus 24 Cochlear Implant System - P970051/S205
- Do Not Use E25Bio COVID-19 Tests: FDA Safety Communication
- MedSun Newsletter, February 2022
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200080 Decision Summary Added)
- Federal Register: Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act
February 3, 2022
- CDRH Strategic Priorities and Updates (Updated)
- Federal Register: Cardiovascular Devices; Classification of the Photoplethysmograph Analysis Software for Over-the-Counter Use
- Federal Register: General and Plastic Surgery Devices; Classification of the Carbon Dioxide Gas Controlled Tissue Expander
- Federal Register: General Hospital and Personal Use Devices; Classification of the Alternate Controller Enabled Infusion Pump
- Federal Register: Immunology and Microbiology Devices; Classification of the System for Detection of Microorganisms and Antimicrobial Resistance Using Reporter Expression
February 2, 2022
February 1, 2022
- MQSA National Statistics
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - February 9, 2022