News and Updates
On October 13, 2021, the FDA issued the draft guidance: Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. This draft guidance is not for implementation at this time. The FDA developed this draft guidance to revise “Section III. Policy On Standard Date Formatting, UDI Labeling, and GUDID Submission Requirements for Class I and Unclassified Devices” of the guidance Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking, (“2020 UDI Compliance Policy Guidance”) that was issued on July 1, 2020. This draft guidance explains that there are certain class I devices for which the FDA does not intend to enforce Global Unique Device Identification Database (GUDID) submission requirements under 21 CFR 830.300. Comments can be submitted to the docket for consideration by the FDA.
On June 26, 2014, the FDA issued the Global Unique Device Identification Database (GUDID): Guidance for Industry. This guidance describes key GUDID concepts such as account management, user roles, the device identifier (DI) module, DI record life-cycle, package configurations, and the two GUDID submission options (web interface and HL7 SPL).
The FDA encourages labelers of all classes of devices to refer to the guidance to establish accounts and submit necessary data to the GUDID. The FDA is committed to assisting companies to comply with UDI requirements and submit data to the GUDID in a timely and successful manner.
The FDA is also making available, as separate technical documents, two components of the 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.
- The section formerly identified as "Appendix B", which summarizes the device attribute information that will populate the GUDID, renamed as "GUDID Data Elements Reference Table (April 27, 2020)" and
- The section formerly identified as "Appendix C", which summarizes the UDI formats accepted by the issuing agencies the FDA has accredited to date, renamed as "UDI Formats by FDA-Accredited Issuing Agency (January 27, 2017)."
If, after reading the guidance, labelers have questions on establishing a GUDID account and submitting data, they should submit an inquiry to the FDA’s UDI Help Desk.