CDRHNew - News and Updates
March 22, 2022
- Reissued Emergency Use Authorization
- Updated Emergency Use Authorization
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
March 21, 2022
- Class I Recall: Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm
- Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
March 18, 2022
- New Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- qSanger-COVID-19 Assay (BillionToOne, Inc.)
- Diagnovital SARS-CoV-2 Real-Time PCR Kit (RTA Laboratories Biological Products Pharmaceutical and Machinery Industry)
- CentoFast-SARS-CoV-2 RT-PCR Assay (CENTOGENE US, LLC)
- CentoSure SARS-CoV-2 RT-PCR Assay (CENTOGENE US, LLC)
- DiaSorin LIAISON SARS-CoV-2 IgM Assay (DiaSorin Inc.)
- At-Home OTC COVID-19 Diagnostic Tests (Updated)
- Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication
- At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
- Presentation and Transcript added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - March 9, 2022
- Consumer Information on: eCoin Peripheral Neurostimulator – P200036
- Consumer Information on: FoundationOne CDx – P170019/S029
- Federal Register: Revocation of Authorization of Emergency Use: In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19
March 17, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (FoundationOne CDx updated)
- Celltrion USA Recalls Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life (Updated)
- Fact Sheet: Mitigating and Preventing Medical Device Shortages and Prioritizing Public Health
March 16, 2022
- New Emergency Use Authorization
- Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication (Updated)
- Class I Recall: SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results
- CDRH Learn Module Updates:
- Presentation and Transcript added for COVID-19 Transition Policy for Devices, Draft Guidances
- Presentation and Transcript added for Patient-Reported Outcome Instruments for Use in Medical Device Evaluation, Final Guidance
- 24 Hour Summary and Presentations for March 2, 2022 Device Good Manufacturing Practice Advisory Committee Meeting
March 15, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Presentation and Transcript added to: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices - February 22, 2022
- February 2022 PMA Approval List
- Children and Teens and Cell Phones (Updated)
- Scientific Research Jobs, Fellowships, and Collaborations on Medical Devices (Updated)
- Science and Research | Medical Devices (Updated)
- Class I Recall: Celltrion USA Recalls Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life
- Federal Register: Medical Device Accessories
March 14, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- xMAP SARS-CoV-2 Multi-Antigen IgG Assay (Luminex Corporation)
- Dimension Vista SARS CoV 2 IgG (COV2G) (Siemens Healthcare Diagnostics Inc.)
- Dimension EXL SARS CoV 2 IgG (CV2G) (Siemens Healthcare Diagnostics Inc.)
- CLINITEST Rapid COVID-19 Antigen Self-Test (Siemens Healthineers)
- MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
- Essure Permanent Birth Control (Updated)
- Essure Benefits and Risk (Updated)
- Information for Patients and Health Care Providers: Essure (Updated)
- FDA Activities Related to Essure (Updated)
- Problems Reported with Essure (Updated)
- Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions (Updated)
- Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (Updated)
- FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication
- LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not Authorized, Cleared, or Approved by the FDA
- Federal Register: Agreement for Shipment of Devices for Sterilization
March 11, 2022
- Voluntary eSTAR Program (Updated)
- Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication (Updated)
- Class I Recall: Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events
- Federal Register: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation
- Federal Register: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Interoperable Automated Glycemic Controller
March 10, 2022
- Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions (Updated)
- Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication (Updated)
March 9, 2022
- Class I Recall: Medtronic Recalls TurboHawk Plus Directional Atherectomy System Due to Risk of Tip Damage During Use
- Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests for Serial Testing (Updated)
- Job Opportunities at OSEL (Updated)
March 8, 2022
March 7, 2022
- New Emergency Use Authorizations
- MedSun Newsletter: March 2022, Volume 22, Issue 3
March 3, 2022
- New Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Updated Emergency Use Authorizations
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Federal Register: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation
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