New FDA Affirmation of Compliance Codes for Medical Device Kits
U.S. Customs and Border Protection reports that the Food and Drug Administration has created two new affirmation of compliance (AofC) codes, KIT and DDM, to address imports of kits containing finished medical devices. Code KIT will be used to clearly identify that the finished devices are part of a kit, while code DDM will be used to facilitate the identification of the manufacturer of any individual device within the kit that was manufactured in the U.S. (American goods returned). DDM is only to be used for those U.S.-manufactured devices declared as part of a kit and should therefore only be used in conjunction with KIT. Codes DEV/DFE should continue to be used for foreign manufacturers or exporters of individual finished devices within kits.
CBP notes that this message only applies to medical device kit importers who have been specifically informed by CBP that they must transmit every device contained in a kit on a separate line (also referred to as X and V lines). Importers of medical device kits who transmit only the kit as a single line should continue to use codes DEV (foreign manufacturer medical device registration #) and LST (medical device listing #) applicable for the kit.