The 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.
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.