Medical Devices

GUDID Guidance

FDA has issued the complete Global Unique Device Identification Database (GUDID): Guidance for Industry (June 26, 2014). 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).

Currently, the FDA is encouraging labelers of class III devices, and devices licensed under the Public Health Service Act, to refer to the guidance to establish accounts and begin submitting 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.

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.

Page Last Updated: 04/15/2016
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