The FDA will require premarket approval (PMA) for automated external defibrillators (AEDs), making manufacturers face a more rigorous review process than had previously been in place.
The FDA issued a final order and outlined the requirements and timetable for the move. The PMA will allow the FDA to assess the safety and reliability of the devices and accessories as well as review a manufacturer’s quality systems. After approval, AED makers will be required to inform the FDA of device changes that might affect safety and effectiveness. They also will be required to submit annual reports on the devices’ performance.
The FDA instructed manufacturers to notify the agency by April 29 of their intent to file for a PMA. It said it would not enforce the PMA requirement until July 29, 2016, if companies have demonstrated their intent.
It also doesn’t plan to enforce the PMA requirement on currently marketed AED accessories until Jan. 29, 2020. Accessories include items such as batteries, pad electrodes, adapters and hardware keys for pediatric use.
In the meantime, consumers will continue to have access to AEDs that are on the market while the companies pursue PMAs.