AED Failures Prompt FDA To Require Premarket Approval Of Emergency Heart Devices

AED Failures Prompt FDA To Require Premarket Approval Of Emergency Heart Devices

ROCKVILLE, Md. - After receiving about 45,000 reports of failures of automated external defibrillators (AEDs) over an eight-year period, the Food and Drug Administration on March 22 proposed that manufacturers be required to submit premarket approval (PMA) applications for the devices.

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