CDRHNew - News and Updates
July 19, 2022
- Supplies of Medical Devices for COVID-19: Frequently Asked Questions (Updated)
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
- Medical Device Types to Help Determine Section 506J Notification Obligations (Updated)
- Medical Gowns (Updated)
July 18, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use AUthorizations
- Updated Emergency Use Authorizations
- Tracking Your Premarket Submission’s Progress (Progress Tracker) (Updated)
July 15, 2022
- Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
- CDRH Petitions (Updated)
- Presentations for July 12-13, 2022 Patient Engagement Advisory Committee Meeting
July 14, 2022
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Class I Recall: American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210045 added)
July 13, 2022
- Revised Emergency Use Authorizations
July 12, 2022
- New Emergency Use Authorization
July 11, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- SalivaDirect At-Home Collection Kit (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)
- Procleix SARS-CoV-2 Assay (Grifols Diagnostic Solutions, Inc.)
- Abbott RealTime SARS-CoV-2 (Abbott Molecular Inc.)
July 8, 2022
- Meeting Materials for July 12-13, 2022 Patient Engagement Advisory Committee Meeting
- 510(k) Third Party Review Organization Performance Report FY22 - Q3
July 7, 2022
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - July 27 and August 24
- Webcast Links for July 28-29, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
July 6, 2022
- Class I Recall: Getinge USA Sales Inc Recalls Flow-c and Flow-e Anesthesia Systems for Cracked or Broken Suction System Power Switches
- MedSun Newsletter - July 2022
July 5, 2022
- Updated Emergency Use Authorizations
- At-Home OTC COVID-19 Diagnostic Tests (InBios International and SD Biosensor updated)
- Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar (InBios International and SD Biosensor actualizado)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210004 added)
- Federal Register: Public Advisory Panels of the Medical Devices Advisory Committee
June 30, 2022
- Personal Protective Equipment EUAs - Appendix A: Authorized Surgical Masks (Updated)
- Mammography Facilities with Revoked MQSA Certificate (Capitol Radiology, LLC 06-30-22)
- Mammography Facility Adverse Event and Action Report - June 30, 2022: Capitol Radiology, LLC doing business as Laurel Radiology Services
- Mammography Facility Adverse Event and Action Report - June 30, 2022: Medical University of South Carolina Hollings Cancer Center - Mobile Health Unit
- Update: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication
June 29, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Medical Device Single Audit Program (MDSAP) (Updated)
- Federal Register: Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers
June 28, 2022
- Class I Recall: GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down
- Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication
- CDRH Petitions (Updated)
June 27, 2022
- Revised Emergency Use Authorizations
- Transcript and Presentation added to Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - June 15, 2022
June 24, 2022
- Reissued Emergency Use Authorization
- Consumer Information on: FoundationOne CDx - P170019/S014
- FAQs on Viral Transport Media During COVID-19 (Updated)
- Federal Register: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation
June 23, 2022
- Reissued Emergency Use Authorizations
- Class I Recall: Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use
- Class I Recall: Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - 06/29/2022 (Updated)
- Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar (fecha de vencimiento)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN190037 and DEN190055 added)
- Federal Register: Agency Information Collection Activities; Proposals, Submissions, and Approvals: 510(k) Third-Party Review Program
- Federal Register: Dear Healthcare Provider Letters: Improving Communication of Important Safety Information
- Federal Register: Establishment Registration and Device Listing for Manufacturers and Importers of Devices
June 21, 2022
- Pruebas de diagnóstico de COVID-19 en el hogar: Preguntas frecuentes
- Class I Recall: Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow to Patients
- Pulse Oximeter Accuracy and Limitations: FDA Safety Communication (Updated)
June 17, 2022
- Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures - Draft Guidance for Industry and Food and Drug Administration Staff
- Laparoscopic Power Morcellators (Updated)
- FAQs on Viral Transport Media During COVID-19 (Updated)
June 16, 2022
- Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 - 04/19/2022 (Updated)
- May 2022 PMA Approval List
June 15, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff
- CDRH Petitions (Updated)
- Federal Register: Administrative Procedures for Clinical Laboratory Improvement Amendments
- Federal Register: Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions