AMCO International Manufacturing & Design, Inc.

CMS # 681557

June 25, 2024 Dear Adam Milewski:

During an inspection of your firm located at 410 Conselyea Street, Brooklyn, NY on March 11, 2024, through March 20, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of replacement batteries (AMCO Part Numbers AM9146-2, AM5070, AM1000, 5L318, 6L785, 5L500, and AM9141) for use in Automated External Defibrillators (AEDs). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

The Center for Devices and Radiological Health (“CDRH”) of the Food and Drug Administration (FDA) published a final order entitled “Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems” in the Federal Register (80 FR 5674) effective on February 3, 2015. AED systems consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use) (“necessary AED accessories”). The final order required the submission, by May 4, 2015, of a premarket approval (“PMA”) application for AEDs and necessary AED accessories that were in commercial distribution before May 28, 1976, or that were, by May 4, 2015, found to be substantially equivalent to any AED or necessary AED accessory that was in commercial distribution before May 28, 1976.

At the time of the final order, FDA announced its intent not to enforce compliance with the 90 day deadline to submit a PMA for then currently marketed AEDs for 15 months after the deadline, provided certain qualifications were met. FDA also stated that it did not intend to enforce compliance with the PMA submission requirement for necessary AED accessories for 60 months following the February 3, 2015, effective date of the final order, which was February 3, 2020.

On October 28, 2020, FDA issued the guidance document, “Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date,” to revise its compliance policy regarding the deadline for filing PMA applications for previously cleared necessary AED accessories. The purpose of this guidance was, in part, to present a less burdensome policy consistent with the public health given the challenges related to the Coronavirus Disease 2019 (COVID-19) pandemic. The guidance outlined that FDA did not intend to enforce compliance with the premarket approval requirements under section 515 of the Act for necessary AED accessories for AED systems, classified under 21 CFR 870.5310 and product codes MKJ and NSA, until February 3, 2022.

Our inspection revealed that your firm manufactures batteries that are used with AED systems, specifically part number AM9146-2 intended to be used with the Cardiac Science Powerheart G3 and G3 Plus devices, part number AM5070 intended to be used with the Philips HeartStart FRx, OnSite, and Home devices, and part number AM1000 intended to be used with the Physio-Control LifePak 1000 device.1 FDA has determined that your firm has not submitted a PMA by the February 3, 2022, compliance date for these devices and that your firm has continued to manufacture and distribute these devices after the compliance date.

Consequently, your devices are adulterated under section 501(f)(1)(A) of the Act, 21 U.S.C. § 351(f)(1)(A), because they have been required by an order issued under section 515(b) of the Act, 21 U.S.C. § 360e(b), to have an approval under such section of an application for premarket approval, are not exempt from section 515 under section 520(g) of the Act, 21 U.S.C. § 360j(g), and your firm has not filed an application for premarket approval by the compliance date cited above.

The kind of information that your firm needs to submit in order to obtain approval for the devices is available through the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether your products may be legally marketed.

FDA requests that your firm cease activities that result in the adulteration of necessary AED accessories.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent to: Gina Brackett, Director of Compliance Branch, at oradevices1firmresponse@fda.hhs.gov. Refer to CMS # 681557 when replying. If you have any questions about the contents of this letter, please contact Compliance Officer, Karen Archdeacon at 781-587-7491 or at karen.archdeacon@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.