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.
"Manufacturers have also conducted dozens of recalls. The problems the FDA is seeing with AEDs are preventable and correctable. The most common issues involve the design and manufacture of the devices and inadequate control of components purchased from other suppliers," according to the release.
"Automated external defibrillators save lives," Dr. William Maisel, chief scientist at the FDA’s Center for Devices & Radiological Health, said in prepared remarks. "However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we’re committed to working with manufacturers to address these issues."
The FDA said it plans to take comments on the proposal for 90 days. If finalized, "the FDA intends to exercise enforcement discretion for those manufacturers that notify the FDA of their intent to file a PMA in a timely manner. The FDA intends to exercise enforcement discretion for a year and a half," according to the release.