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# Guidance on Unique Device ID Kits
- URL: https://www.fdaweb.com/guidance-on-unique-device-id-kits/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:20.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134317

*Federal Register* Notice: FDA is making available a draft guidance entitled *Unique Device Identification: Convenience Kits; Draft Guidance for Industry and Food and Drug Administration Staff*. It is intended to outline the agency’s current thinking that for purposes of Unique Device Identification (UDI) labeling and data submission requirements, the term “convenience kit” applies solely to two or more different medical devices packaged together for the convenience of the user, where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user. To download this guidance, click [here.](http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM479242?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-04/pdf/2015-33008.pdf?ref=fdaweb.com)