In the February 3, 2015, Federal Register, FDA republished its final order Effective Date of Requirement for Premarket Approval for Automated External Defibrillator (originally published in the January 29, 2015, Federal Register) to correct an inadvertent omission of a comment regarding adverse tissue reaction as a risk to health and the Agency's response to that comment. The final order requires the filing of premarket approval applications ("PMA") for automated external defibrillator ("AED") systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use). Effective May 4, 2015 (for AEDs and accessories legally marketed by that date).
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