FDA Issues New AED Approval Guidelines

The FDA has announced new approval criteria for the next generation of AED (Automated External Defibrillators) devices to make them more robust, reliable and safer.

“It’s not that the old AEDs are bad, it’s just that newer ones will be even more reliable. AEDs absolutely do save lives!”

The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices.

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 William Maisel, M.D., M.P.H, 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.”

Read the complete FDA press release HERE

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431907.htm

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