FDA yesterday issued a proposed order “aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs).” The proposed order, if finalized, will require manufacturers of these life-saving devices to submit premarket approval (PMA) applications.

PMA applications are required to contain clinical data to support a product’s approval. In addition to the clinical safety and effectiveness data, a PMA must also include a review of a manufacturer’s quality systems information and an inspection of its manufacturing facilities. After approval, manufacturers must submit to FDA any significant manufacturing changes made to the devices as well as annual reports of the device’s performance.

FDA has received approximately 45,000 adverse event reports between 2005 and 2012 associated with the failure of AEDs. Manufacturers have also conducted dozens of recalls. The most common issues involve the design and manufacture of the devices and inadequate control of components purchased from other suppliers, according to an FDA news release. The release goes on to state that the FDA will make sure that automated external defibrillators remain available so that they can continue to save lives.

The recently enacted Food and Drug Administration Safety and Innovation Act calls for  the FDA to publish a proposed and final order to reclassify or call for PMAs for a pre-amendments device. The FDA’s Circulatory System Devices Panel recommended that AEDs remain Class III medical devices and require PMAs. FDA is issuing this proposed order and calling for PMAs as part of the 515 Program to ensure the appropriate regulation of Class III pre-amendments devices.

FDA will take comments on the proposed order for 90 days. If the proposed order is finalized, 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.