Effective date of requirement for premarket approval for automated external defibrillator systems. Final rule.
The Food and Drug Administration (FDA or the Agency) is issuing a final order to require 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).
D047548:Defibrillators / Q000145:classification*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D006801:Humans; D062307:Medical Device Legislation; D014481:United States