FINAL ORDER: Premarket Approval for AED Systems:


The FDA issued a Final Order: Premarket Approval for Automated External Defibrillator System on January 28, 2015, which represents a tailored approach to help manufacturers assure the quality and reliability of AEDs. AEDs can be highly effective in saving the lives of people suffering cardiac arrest when used in the first few minutes following collapse from cardiac arrest. To help to assure the quality and reliability of AEDs, the FDA is requiring manufacturers to obtain premarket approval for all future and currently-marketed AEDs and necessary AED accessories (e.g., pad electrodes, batteries, adapters and hardware keys for pediatric use).
Top Bottom