FDA Updates
Published: 08/18/2023
Sources:
- Food and Drug Administration
Relevant To:
- All Healthcare Organizations
The following is a listing of recent U.S. Food and Drug Administration (FDA) updates and activities:
- Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots
- Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the Ability to Charge the Batteries Leading to Unexpected Shutdowns
- FDA Issues Final Guidance - Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors