The Food & Drug Administration may make it harder for companies to bring their automated external defibrillators to market.
Amidst increased reports of device malfunctions, the FDA called for its circulatory systems devices panel to consider whether the devices should be subject to the agency’s pre-market approval application process, or PMA, in order to reach the marketplace.
The PMA system is a significantly more arduous regulatory pathway because it requires stricter manufacturing guidelines and more information reporting. AEDs, which are indicated to treat individuals suffering from sudden cardiac arrest and installed widely in public places, currently undergo the 510(k) process, through which most medical devices are cleared for the marketplace.
The advisory committee meet tomorrow and will weigh in on the agency’s external defibrillator improvement initiative, which, besides calling for stricter regulations on the devices, set out plans to promote more innovation for AEDs.