Unique Device Identification Program: The FDA Finalizes Guidance for Convenience Kits

This final guidance, “Unique Device Identification: Convenience Kits,” describes the FDA’s interpretation of the definition of “convenience kit” for purposes of applying unique device identifier (UDI) requirements only. The FDA is issuing this final guidance to: Clarify the FDA’s policy related to UDI considerations for “medical procedure kits” Help ensure that the exception for UDI labeling of devices within the immediate container of a convenience kit is applied in a way that provides adequate identification of devices through distribution and use. Save the Date The FDA will host a webinar to share information and answer questions about the implementation of the final guidance on Tuesday, May 21, 2019, from 3:00 p.m. to 4:30 p.m. Registration is not necessary.

Read the Guidance

Questions? If you have questions about this final guidance, contact the UDI Help Desk.