FDA Alerts

Use Duodenoscopes with Innovative Designs to Enhance Safety

FDA Roundup: April 5, 2022

FDA Releases MDUFA Statement

FDA Issues Proposal to Amend Medical Device Quality System Regulation

CDRH 2021 Annual Report

Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use

FDA Issues Draft Guidance on 506J Notifications for Medical Devices

Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure

Update: Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

FDA, ECRI Partner on Materials Safety in Medical Devices