The FDA recently issued a final order requiring "more rigorous review" of automated external defibrillators (AEDs) in order to improve the safety and reliability of such medical devices on the market.
AEDs are portable devices used to "provid[e] a rapid response to victims of cardiac arrest" by "automatically analyz[ing] the heart rhythm... and deliver[ing] an electrical shock to the heart to restore its normal rhythm." While AEDs can be lifesaving, they have also been associated with numerous failures and recalls. Specifically, between January 2005 and September 2014, "the FDA received approximately 72,000 medical device reports associated with the failure of these devices." Also since 2005, over two million AEDs have been withdrawn from the market by manufacturers in a total of 111 recalls. Significantly, "many of these recalls and reports [were associated with failures stemming from] design and manufacturing issues..."
Under the current approval regime for AEDs, manufacturers are not required to report all postmarket changes to the devices that might affect their safety. Moreover, the FDA has observed that "many of the design and manufacturing changes that have led to AED system recalls were not required to be reported to FDA under the [existing regulatory] process." In order to "provide a reasonable assurance of safety... of these devices given safety concerns related to the manufacturing processes and design changes," the FDA will require "premarket approval [PMA] for all future and currently-marketed AEDs..."
Manufacturers of AEDs and AED accessories currently on the market are required to submit a PMA to the FDA by April 29, 2015.