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Talk to a SpecialistTalk to a SpecialistAMCO International Manufacturing & Design, Inc. manufactured replacement batteries for Automated External Defibrillators (AEDs) without obtaining required premarket approval, violating FDA regulations that mandate PMA submissions for AED accessories. During a March 2024 inspection, the FDA determined that the company's batteries—including models AM9146-2, AM5070, AM1000, 5L318, 6L785, 5L500, and AM9141—qualified as medical devices requiring premarket approval under a 2015 final order effective February 3, 2015. The company failed to submit required PMA applications for these necessary AED accessories, which are critical components for AED functionality in detecting heart rhythms and delivering electrical shocks.