News and Updates
On June 22, 2022, the FDA posted the final guidance Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices. This final guidance describes the FDA's compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The update to this guidance reflects the finalization of the draft guidance "Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices", which was issued October 14, 2021, and following the consideration of public comments. This final guidance describes the FDA's compliance policy regarding GUDID submission requirements for certain Class I devices considered consumer health products. Additionally, the FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022. I/LS/LS devices, including Class I I/LS/LS devices, are already expected to comply with GUDID submission requirements. This new date provides a 75-day extension of an existing FDA compliance policy published in the July 2020 version of this guidance.
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 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 UDI Help Desk.