This action is being taken based on the recommendation of the FDA's Circulatory System Devices Panel, which wants AEDs to be a Class III medical device requiring pre-market approval.
AEDs were on the market before the current approval process for Class III medical devices was updated, so they didn't need pre-market approval. But given their problems they should now require approval, Maisel said.
In addition to the safety and effectiveness data, the application must include a review of a manufacturer's quality systems and an inspection of its plant.
According to the FDA, after the device is approved, the manufacturer must submit any significant changes made to the device, as well as a yearly report on the device's performance.
The public will have 90 days to comment on the FDA proposal. When the proposal becomes final, the process of getting all AEDs approved will take about two years, Maisel said.
For more information on automated external defibrillators, visit the U.S. National Heart, Lung, and Blood Institute.
SOURCES: Moshe Gunsburg, M.D., director, cardiac arrhythmia service, co-chief, division of cardiology, Brookdale University Hospital and Medical Center, Brooklyn, N.Y.; March 22, 2013, press conference with William Maisel, M.D., M.P.H., deputy director of science and chief scientist, Center for Devices and Radiological Health, U.S. Food and Drug Administration; The New York Times
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