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UDI: FDA Finalizes Guidance for Convenience Kits

The guidance features clarification of concepts, examples and a Q&A section to help manufacturers determine when individual components of a kit require labeling.

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.

Upcoming webinar

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.

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