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FDA Advocates PMAs For Automated External Defibrillators

This article was originally published in The Gray Sheet

Executive Summary

Automated external defibrillators may require review via the pre-market approval (PMA) route in coming years, according to a preliminary FDA assessment and advisory panel input.

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FDA Sets PMA Standard For AEDs, Giving Marketed Devices Time To Comply

FDA issued a final order on Jan. 28 requiring manufacturers of automated external defibrillators to submit premarket approval applications to market their products. This will immediately apply to new AEDs, but manufacturers of devices already on the market have 18 months to submit PMAs for those devices as long as they notify the agency by April 29.

Industry Fights FDA’s PMA Proposal For External Defibrillators

Makers of automated external defibrillators are vigorously opposed to FDA’s proposal to require PMAs for the devices. A petition submitted by Philips Healthcare asks the agency to reclassify the devices into class II with special controls.

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