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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: