FDA Sets PMA Standard For AEDs, Giving Marketed Devices Time To Comply
This article was originally published in The Gray Sheet
Executive Summary
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.
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