The U.S. Food & Drug Administration (FDA) has issued the first phase of its Global Unique Device Identification Database (GUDID): Guidance for Industry on June 11, 2014. To quickly provide industry with information critical to successful use of the GUDID, the FDA is issuing the GUDID Guidance in two phases.
The first phase includes updates to sections on establishing and using a GUDID account, the unique device identifier, and Global Medical Device Nomenclature (GMDN), as well as 21 CFR Part 11requirements for electronic records and signatures. Also included in this phase are GUDID attributes mapped to a fictitious medical device label and a glossary.
This guidance identifies several sections that will be finalized in the next phase, which is expected in the coming months. Until these sections are finalized, users may refer to the Global Unique Device Identification Database (GUDID) draft guidance (dated September 24, 2013).
The FDA is also making available updated versions of two components of the draft GUDID Guidance. These two files contain technical specifications only that do not describe the agency's interpretation of or policy on a regulatory issue, and the FDA will not publish them as part of the GUDID guidance in the future.
