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FDA Updates

Published: 04/01/2023

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

The following is a listing of recent U.S. Food and Drug Administration updates and activities:

  • Recall by Datascope/Getinge of Certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) for Risk of Unexpected Shutdown After PCBA Communication Loss
  • Problems Reported with Essure
  • Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Pr…

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