FDA Tightens AED Regulations

The FDA today announced that it plans to implement a more stringent review process for automated external defibrillators (AEDs) in an effort to improve the devices’ quality and reliability.

In accordance with the FDA's new regulations, AED manufacturers will be required to submit premarket approval applications (PMAs), which are evaluated more rigorously than previous requirements. The new review process will focus on ensuring that AEDs and their necessary accessories are reliable and safe.

The FDA will also inspect manufacturers’ facilities prior to granting approval to their AEDs. After a device has been approved, its manufacturer will be required to submit changes that might affect safety or effectiveness, as well as annual performance reports.

“Automated external defibrillators save lives,” said William Maisel, MD, MPH, deputy director for science, chief scientist and acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in a press release. “These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”

Approximately 72,000 medical device reports associated with AED failure were submitted to the FDA between January 2005 and September 2014, with manufacturers having conducted 111 recalls affecting more than 2 million AEDs since 2005. Many of these recalls and reports were linked to design and manufacturing issues.

The FDA does not plan to enforce the PMA requirement for AEDs until July 29, 2016, but it is requiring that manufacturers notify the agency of their intent to file a PMA by April 29, 2015. In addition, the FDA does not plan to enforce the PMA requirement for currently marketed, necessary AED accessories until January 29, 2020. Currently marketed AEDs will remain available while manufacturers work to meet the new FDA standards.