FDA Alerts

Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing

GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of the Backup Batteries that May Cause Unexpected Shut Downs

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FDA Issues Draft Guidance on 506J Notifications for Medical Devices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