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Automated external defibrillators are portable, electronic medical devices that automatically sense potentially life-threatening cardiac arrhythmias and either automatically deliver or advise the user to deliver electrical stimulation to re-establish normal heart rhythms.
They are often stored in public locations for use in an emergency and, while they can be lifesaving, there has been a history of malfunction issues.
The FDA issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these devices in the past.
The agency's strengthened review will focus on the critical requirements needed to ensure the safety and reliability of AEDs and their necessary accessories, including batteries, pad electrodes, adapters and hardware keys for pediatric use.
"Automated external defibrillators save lives," said Mr William Maisel, deputy director for science, chief scientist and acting director of the office of device evaluation in the FDA's Center for Devices and Radiological Health. "These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices."