CSMS Message: 11-000315

TITLE: OGA-FDA Affirmation of Compliance, KIT- imported kit of finished devices and DDM- Domestic Device Manufacturer

TO: ALL FILERS

FROM: FOOD & DRUG ADMINISTRATION

SUBJECT: Affirmation of Compliance, KIT- imported kit of finished devices and DDM- Domestic Device Manufacturer

FDA has created two new Affirmations of Compliance (AofC), KIT and DDM, to address shipments of kits containing finished devices imported into the United States (U.S.).

In order to clearly identify that the finished devices are part of a kit, a new AofC code KIT has been developed. Additionally, the new AofC code DDM will be used to facilitate 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.

DEV/DFE should continue to be used for the foreign manufacturers or exporters of individual finished devices within the kits.

The AofC code, title, and description are provided below. Use of this code affirms that the product identified in a FDA line meets the requirements specific to the code. While use of the code is voluntary, transmission will help expedite the entry review process.

CODE TITLE/DESCRIPTION

KIT Imported kit of finished devices

The code KIT should be used for all individual devices within kits imported in the US. There is no associated qualifier.

DDM Domestic Device Manufacturer

The code and qualifier should be the device registration number issued by CDRH for the US firm manufacturing the product identified in the FDA line. DDM should be used only in conjunction with KIT.

Additionally, some kits contain drug products which must comply with applicable labeling and approval requirements including but not limited to application number, registration, and listing. For example, the foreign firm's drug registration per FFDCA 510(i) must include the known US importers. If the registration does not include the importer or consignee, then detention may be indicated.

Kit importers should consider obtaining the Affirmation of Compliance information from their vendors to minimize the need for manual review of applicable lines by the FDA.

NOTE: The information in this transmission 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 the affirmations of compliance codes DEV (foreign manufacturer medical device registration #) and LST (medical device listing #) applicable for the medical device kit.