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FDA Sets PMA Standard For AEDs, Giving Marketed Devices Time To Comply

FDA issued a final order on Jan. 28 requiring manufacturers of automated external defibrillators to submit premarket approval applications to market their products. This will immediately apply to new AEDs, but manufacturers of devices already on the market have 18 months to submit PMAs for those devices as long as they notify the agency by April 29.

FDA will require PMA submissions for automatic external defibrillators stepping up from the prior 510(k) submission standard for these devices, the agency announced Jan. 28.

Under the new order, which had been widely anticipated, any new AEDs or new AED accessories must go through the...

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