Medical Devices

Automated External Defibrillators (AEDs)

An automated external defibrillator (AED) is a device that automatically analyzes the heart rhythm in victims of cardiac arrest, and delivers an electrical shock to the heart to restore its normal rhythm. AEDs are important tools in providing a rapid response to victims of cardiac arrest.

An AED system consists of an AED device, battery, pad electrode, and if applicable, an adapter.

AEDs are found in airports, community centers, schools, government buildings, and other public locations. These devices are intended for use by the general public.

AEDs can save lives – but the devices have been associated with manufacturing problems and many devices have been recalled.

The FDA issued a Proposed Order: Premarket Approval for Automated External Defibrillator System on March 25, 2013, which represents a smart, tailored approach to help manufacturers improve the quality and reliability of AEDs. The proposed order will require manufacturers of AEDs and accessories to submit pre-market approval (PMA) applications that focus specifically on the critical requirements necessary to assure AEDs are safe and reliable.

Because these devices save lives, AEDs will remain available during the review of the proposed order, as well as after an order is final. See FDA News Release: FDA issues proposal to improve quality of automated external defibrillators for more information.

Page Last Updated: 06/04/2014
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