In 2015, the FDA published a final order establishing that all Automated Electronic Defibrillators (AEDs) and their accessories require pre-market approval (PMA) based on the adverse event report and product recall history of these devices. AEDs without PMA will no longer be legal after February 3, 2021. Because these devices are critical in emergency situations, CDRH has published a web page with information to help end users transition to approved AEDs as soon as feasible. The centerpiece of the page is a list of AEDs currently approved for public, professional, and home use. If your current AED is not listed, the agency encourages you to contact the manufacturer of your device and to continue to keep it available until you can get an approved replacement.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2019 Katrina Rogers