The FDA issued a proposed order on March 22nd that, if finalized, could potentially toughen the approval process for manufacturers of automated external defibrillators (AEDs). Under the proposed order, manufacturers will now be required to submit a pre-market approval application (PMA) or notice of completion of a product development protocol (PDP). AEDs are used to prevent cardiac arrest in patients by delivering an electrical shock to re-establish normal cardiac rhythms. According to an article by The New York Times reporting on the proposed order:
There have been 45,000 reports of the devices failing or malfunctioning since 2005. . . . The vast majority of them were due to manufacturing problems, . . . but some were because of improper maintenance, like battery failure. Manufacturers have recalled the devices 88 times in that period.
The article notes that while the new regulations would typically require manufacturers to conduct expensive and time-consuming clinical trials, many of the nine U.S. manufacturers of AEDs have already collected the necessary data, according to Dr. William Maisel, the chief scientist at the FDA’s Center for Devices and Radiological Health. For these manufacturers, Dr. Maisel stated that the cost of complying with the new regulations would rise from about $5,000 to about $220,000.