The FDA will now ensure all Automated External Defibrillators in use currently and all future AED devices are reliable life-saving devices. Premarket approval is now required by the FDA for manufacturers of AEDs
In the past, many AEDs were manufactured using inadequate components, insufficient validation of the manufacturing processes along with design issues. In 2013, the FDA alerted users of certain models of AEDs manufactured between 2005 and 2012 that their AED may not deliver a shock to the patient in an emergency situation. Faulty AEDs can result in patient injury or prevent patient rescue.