FDA Releases First Phase of Global UDI Database
First phase of the Global Unique Device Identification Database (GUDID): Guidance for Industry is now available. To quickly provide industry with information critical to successful use of the GUDID, we are issuing the GUDID Guidance in two phases. 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.
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 Until these sections are finalized, users may refer to the Global Unique Device Identification Database (GUDID) Draft Guidance (dated September 24, 2013).
Also note that updated versions of two sections of the draft GUDID Guidance for Industry document are on our website, www.fda.gov/udi. These two sections contain technical specifications only and do not describe the Agency’s interpretation of or policy on a regulatory issue, and the FDA will not publish these as part of the GUDID guidance document in the future. The two sections are --
The section formerly identified as Appendix B, which summarizes device attribute information that will populate the GUDID, has been renamed as the “GUDID Data Elements Reference Table”
The section formerly identified as Appendix C, which summarizes the UDI formats by the Issuing Agencies accredited by the FDA to date, has been renamed as “UDI Formats by FDA Accredited Issuing Agency”
For all questions on UDI and GUDID, please contact the FDA UDI Help Desk.