The Food and Drug Administration plans to require the manufacturers of automated external defibrillators to submit pre-market approval applications for those devices as part of a broader effort to reclassify how some high-risk devices are regulated.
The agency said in a statement that the proposed order is expected to improve the quality and reliability of AEDs.
There have been at least 45,000 malfunctions and adverse events and 88 recalls of AEDs during a seven-year period beginning in 2005.
AEDs are classified as Class 3 devices, which are considered the most high-risk devices on the market. Yet they have traditionally been cleared through the FDA's expedited 510(k) process, which is less stringent and does not require clinical testing to gain marketing clearance.
“Automated external defibrillators save lives,” Dr. William Maisel, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a news release. “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.”