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# Final Guide on UDI Convenience Kit Labeling
- URL: https://www.fdaweb.com/final-guide-on-udi-convenience-kit-labeling/
- Published: 2019-04-25T12:00:00.000Z
- Updated: 2026-09-15T01:22:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143962

FDA has released a [final guidance](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM479242.pdf?ref=fdaweb.com) on “Unique Device Identification: Convenience Kits.” The document discusses an agency exception for complying with unique device identification (UDI) system regulations that require that the label and device package of a device must bear a UDI. The exception is provided for devices packaged within the immediate container of a convenience kit, if the convenience kit label bears a UDI. The guidance also describes FDA’s interpretation of “convenience kit.” It does not apply to in vitro diagnostic (IVD) devices that aresubject to IVD labeling requirements. Regulations define a “convenience kit” as “two or more different medical devices packaged together for the convenience of the user.”