FDA Proposes to Require PMAs for Automated External Defibrillators
The Food and Drug Administration is proposing to require premarket approval for automated external defibrillator (AED) systems. Should FDA finalize its proposed order, a pre-market approval (PMA) application or notice of development of product development protocol (PDP) will be required before commercial distribution of the class III devices. Comments on the proposed order are due by June 24.
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The PMA requirement for AED systems would be effective 90 days from issuance of the final order. However, FDA said it is considering exercising enforcement discretion for 15 months after the final order for legally distributed products, as long as the manufacturer notifies FDA of its intent to file a PMA within 90 days from the final order.
(Federal Register 03/25/13)