CDRHNew - News and Updates
September 23, 2022
September 22, 2022
- Revoked Emergency Use Authorization
- Revised Emergency Use Authorization
- Virtual Town Hall Series - Test Development and Validation (COVID-19 and Monkeypox) - September 28, 2022
September 21, 2022
- Electronic Submission Template for Medical Device 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff
- eCopy Program for Medical Device Submissions (Updated)
- Tracking Your Premarket Submission's Progress (Progress Tracker) (Updated)
- Office of Product Evaluation and Quality (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN220025 added)
September 20, 2022
- Information on Cybersecurity (Updated)
- Medical Device Development Tools (MDDT) (Updated)
September 19, 2022
- Virtual Town Hall Series - Monkeypox Test Development and Validation (Updated)
- CDRH Learn: Specialty Technical Topics (Updated)
- Presentation and Transcript: Monkeypox Test Development and Validation Webinar - September 14, 2022
September 16, 2022
- Revised Emergency Use Authorization
- ASCA-Accredited Testing Laboratories (Updated)
- Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers
September 15, 2022
- Re-issued Emergency Use Athorizations
- Class I Recall: Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances
- Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
- Meeting Notice: November 1, 2022 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
September 14, 2022
- Re-issued Emergency Use Authorizations
- Presentation and Transcript: Monkeypox Test Development and Validation Webinar - September 14, 2022
September 16, 2022
- Revised Emergency Use Authorization
- ASCA-Accredited Testing Laboratories (Updated)
- Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers
September 15, 2022
- Re-issued Emergency Use Athorizations
- Class I Recall: Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances
- Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
- Meeting Notice: November 1, 2022 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee
September 14, 2022
- Re-issued Emergency Use Authorizations
September 7, 2022
- New Emergency Use Authorization
- Monkeypox and Medical Devices
- Monkeypox Emergency Use Authorizations for Medical Devices
- Policy for Monkeypox Tests to Address the Public Health Emergency - Guidance for Laboratories, Commercial Manufacturers and Food and Drug Administration Staff
- Summary Minutes: July 12-13, 2022 Patient Engagement Advisory Committee Meeting
September 6, 2022
- Revised Emergency Use Authorization
- Updated Emergency Use Authorization
- Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
- Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers
- Personal Protective Equipment EUAs (Updated)
- Mammography Facility Adverse Event and Action Report – September 6, 2022: Memorial MRI & Diagnostic, LLC
- Mammography Facility Adverse Event and Action Report – September 6, 2022: Ste. Genevieve County Memorial Hospital
September 2, 2022
September 1, 2022
- At-Home OTC COVID-19 Diagnostic Tests (Extended Expiration Dates for OHC COVID-19 Antigen Self Test and CareStart COVID-19 Antigen Home Test)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210052 added)
- MQSA National Statistics (Updated)
August 31, 2022
- Class I Recall: Integra Recalls CereLink ICP Monitor for Risk of Incorrect Intracranial Pressure Readings
- MedSun Newsletter, September 2022 (PDF - 4MB)
August 30, 2022
- Revised Emergency Use Authorizations
- Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics, Inc. )
- CareStart COVID-19 Antigen Home Test (Access Bio, Inc.)
- Genabio COVID-19 Rapid Self-Test Kit (Genabio Diagnostics Inc.)
- NIDS COVID-19 Antigen Rapid Test Kit (ANP Technologies, Inc.)
- BioCode CoV-2 Flu Plus Assay (Applied BioCode, Inc.)
- MicroGEM Sal6830 SARS-CoV-2 Saliva Test (MicroGEM U.S., Inc.)
- Revoked Emergency Use Authorizations
- Updated Emergency Use Authorizations
- Transcript for: July 12-13, 2022 Patient Engagement Advisory Committee Meeting
- Transcript for: July 28-29, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
August 29, 2022
- Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication
- Class I Recall: Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump Due to Faster Than Expected Flow Rates That May Impact Infusion Delivery
- Class I Recall: Hamilton Medical AG Recalls Hamilton-C6 Intensive Care Ventilator Due to Potential Water Ingress that May Cause Breathing Support to Stop
August 26, 2022
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
- 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic (Updated)
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
August 25, 2022
- Call I Recall: Medtronic Recalls HeartWare HVAD System Batteries for Electrical Faults That Cause Battery Failure
- Consumer Information on: Stellarex 0.035 OTW Drug-coated Angioplasty Ballon - P160049/S015
- Medtronic HeartWare Ventricular Assist Device (HVAD) System (Updated)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200039 added)
- Transcripts for:
- Virtual Public Workshop – Study Design Considerations for Transbronchoscopic Thermal Ablation Devices for the Treatment of Oligometastases to the Lung
- Virtual Public Workshop – Animal Studies for Orthopedic Products - 06/02/2022
- Virtual Public Workshop - Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration - 06/07/2022
- Federal Register: Authorization and Revocations of Emergency Use of Certain In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19
August 24, 2022
- List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) (Updated)
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Export of Medical Devices; Foreign Letters of Approval
August 23, 2022
- Consumer Information on: BioFreedom Drug Coated Coronary Stent (DCS) System – P190020
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Labeling Regulations
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Humanitarian Use Devices
August 22, 2022
- Reissued Emergency Use Authorization
- Revised Emergency Use Authorizations
- EUA Authorized Serology Test Performance (Updated)
- eMDR