| IN AN EFFORT to make AEDs and AED capable devices more reliable, the FDA made a final order in February 2015 (Section 515(b)(1)(A) of the FD&C Act (21 U.S.C. 360e(b)) stating that current and future devices with an AED function would have to go through the more robust PMA process to carry the FDA’s approval. Not only does this include AED defibrillators for public access but also any ALS defibrillator in professional settings with AED or analyze functions.
Device OEMs are not the only ones required to submit to this PMA ruling. Aftermarket manufacturers of all necessary AED and defibrillator accessories such as batteries, pad electrodes, adapters and other patient hardware must file a PMA by February 3, 2020. As a result, if an AED or AED capable device is not PMA approved, no accessory, part or supplies can be manufactured or marketed after February 2021.
What does this mean for the thousands of AEDs and AED capable ALS devices that are not PMA-FDA compliant? Contrary to some rumors, all previous 510k approved devices have been “grandfathered” in and are still usable as intended until the needed parts or accessories are no longer available in 2021. Most of these devices, which have already been discontinued by the OEMs, were at the end of their life cycle. […read more] |
