The FDA published a final order in February 2015 requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories. Manufacturers of all necessary AED accessories, such as batteries, pad electrodes, adapters and hardware keys for pediatric use, must file a premarket approval application (PMA) by February 3, 2020. If a PMA is not filed by February 3, 2020, the manufacturer must cease marketing their accessories by February 3, 2021. There are now FDA-approved AEDs available, and we encourage you to ensure your AED is FDA-approved; if it is not, you may want to consider beginning making plans to transition to an FDA-approved AED. If you or your organization own(s) an AED system, the FDA recommends you:
- Click this link https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds for the regulations and a table that lists FDA approved devices. Contact the manufacturer of your AED if you are not sure if your AED is FDA-approved. The FDA AED web page was updated November of 2019. The entire page is worth reviewing.
- Contact the manufacturer of your AED if your AED is not FDA-approved and you have not received a letter about your AED.
- Be aware that if your AED is not FDA-approved, compatible necessary AED accessories may no longer be available to support your AED after February 3, 2021.
- Contact the manufacturer of your AED or AED accessories for information specific to your product.
- Given the importance of these devices in emergency situations, the FDA recommends you continue to keep your AED available for use until you receive an FDA- approved AED.
- Report problems with AEDs to the FDA by submitting a voluntary report online at MedWatch: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program