More Oversight Of AEDs Proposed By FDA

Susan Najjar

A proposal to improve the quality and reliability of automated external defibrillators (AEDs) has been issued by the U.S. Food and Drug Administration.  Manufacturers of these life-saving devices will need to send in pre-market approval (PMA) applications if the proposed order is finalized.  While many lives have been saved by AEDs, there have been about 45,000 adverse events reported to the FDA between 2005 and 2012 linked to the failure of these devices.

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