The FDA wants makers of automated external defibrillators to undergo its most stringent medical device approval process before the products can hit the U.S. market.
The federal watchdog agency said today that its proposal would mandate that AED manufacturers submit premarket approval applications, which require clinical trials, rather than using the less-strict 510(k) clearance process.
The FDA said it’s received about 45,000 adverse event reports between 2005 and 2012 involving AEDs, portable medical devices used to shock abnormal heart rhythms back to normal, according to a press release.