Dive Brief:
- The Food and Drug Administration has sent a warning letter to a manufacturer of batteries for automated external defibrillators (AEDs) sold by companies including Philips, Stryker and Zoll.
- The letter, which the FDA published Tuesday, states Amco International Manufacturing & Design continued to supply the batteries after failing to seek premarket approval (PMA).
- Manufacturers of batteries and other AED accessories needed to file a PMA by early February 2022 under changes finalized in 2015.
Dive Insight:
In February 2015, the FDA published a final order on accessories that AEDs require to detect an electrocardiogram and deliver an electrical shock. Under the final order, manufacturers of batteries and other devices such as pad electrodes had 90 days to submit a PMA.
However, the FDA decided not to enforce the PMA requirement for currently marketed AEDs for 15 months, provided certain conditions were met. The agency also agreed to defer enforcement of the PMA submission requirement for necessary AED accessories until February 2020. Later in 2020, the FDA gave companies until February 2022 to submit PMAs for necessary accessories, partly because of COVID-19.
FDA inspectors visited Amco’s facility in New York in March. The inspection showed the company makes batteries for use with AED systems including Cardiac Science’s Powerheart G3, several Philips products and Physio-Control’s Lifepak 1000. Stryker bought Physio-Control in 2016, and Zoll acquired Cardiac Science in 2019.
Amco failed to file a PMA by the February 2022 deadline, according to the FDA, but continued to make and distribute the devices. As such, the agency deemed the devices to be adulterated under U.S. law. The FDA told Amco to “cease activities that result in the adulteration of necessary AED accessories” and take prompt actions to address violations identified in the letter.
The agency dated the letter on June 25. Amco had 15 business days from the receipt of the letter to send a written list of the steps it had taken to address the violations and explain how it planned to prevent the problems from happening again.
Amco works in multiple fields, such as communication and thermal imaging, and calls itself a provider of “replacement batteries that are an affordable alternative to OEM batteries.” The medical section of the company’s website used to list batteries for AEDs from Cardiac Science, Philips, Physio-Control and Zoll. The current medical page is blank.