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Issue Brief
AHRMM Awareness Brief: Draft Guidance for UDI Convenience Kits
This Awareness Brief provides a quick reference to the Draft Guidance for UDI Convenience Kits, released by the FDA in January 2016. The draft guidance defines the term “convenience kit” for purposes of compliance with UDI labeling and data submission requirements only.
Data Standards, Regulations and Regulatory Advocacy, Unique Device Identifier (UDI), Procurement