The Food and Drug Administration has issued a proposed order that would require manufacturers of automated external defibrillators to submit pre-market approval (PMA) applications.
In explaining its rationale for changing the classification of these devices to the most restrictive category, Class III, FDA noted that it “has received approximately 45,000 adverse event reports between 2005 and 2012 associated with the failure of these devices,” and that “manufacturers have also conducted dozens of recalls.”
“Automated external defibrillators save lives,” said William Maisel, MD, MPH, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “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.”
Though PMA submissions generally must include extensive clinical data, FDA has signaled that it will limit the data required for AED applications. “If our proposed order is finalized,” Maisel said, “the FDA intends to focus its review of the pre-market applications on the more problematic aspects of AEDs.”