Industry Fights FDA’s PMA Proposal For External Defibrillators

05 Jul 2013

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.

Industry is fighting FDA’s proposed order to require PMAs for automated external defibrillators, saying the devices’ safety and effectiveness have been demonstrated and the 501(k) route with class II special controls is appropriate.

FDA’s March proposal, if finalized, would require AED manufacturers to submit PMAs for the devices. Since the devices were on...