Amco Receive FDA Warning Over Defibrillator Batteries

A warning letter has been given by the FDA to a producer of batteries for automated external defibrillators (AEDs), which are delivered by businesses such as Stryker, Philips, and Zoll.

According to the document, Amco International Manufacturing & Design neglected to get premarket approval (PMA) and kept supplying the batteries.

Changes made in 2015 required manufacturers of batteries and other AED equipment to register a PMA by early February 2022.

The FDA claims that Amco did not submit a PMA by the deadline in February 2022, yet they were still producing and distributing the devices. According to US law, the agency therefore considered the electronics to be tampered with. Amco was instructed by the FDA to “cease activities that result in the adulteration of necessary AED accessories” and to work quickly to resolve the infractions noted in the letter.