UDI Regulation Compliance: First Phase Guidance Document Issued

Compliance to the UDI regulation includes the FDA public database, GUDID. The first phase of the Global Unique Device Identification Database (GUDID): Guidance for Industry document is now available. The first phase includes updates to sections on establishing and using a GUDID account, managing account changes, Global Medical Device Nomenclature (GMDN), and GUDID submissions and part 11 requirements.

View the guidance document and more information here.

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