FDA Delaying AED Accessory Premarket Approval

FDA says it will not enforce compliance with the PMA requirements for necessary automated external defibrillator (AED) accessories (such as batteries, pad electrodes, adapters, and hardware keys for pediatric use) until 2/3/22. An agency guidance, Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date, says the delayed enforcement is based, in part, on consideration of the burden on healthcare facilities as they transition to FDA-approved AEDs and on the manufacturers as they prepare to implement the PMA requirements while addressing the challenges related to Covid-19.

The document takes effect immediately. It says that in 2/2015, FDA published a final order requiring the submission of PMA applications for new and existing AEDs and AED accessories. Compliance was set for 2/3/20, the guidance says, and then was delayed to 2/3/21 in response to feedback from stakeholders.