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GUIDANCE DOCUMENT

Global Unique Device Identification Database (GUDID) Guidance for Industry and Food and Drug Administration Staff December 2024

Download the Final Guidance Document
Final
Docket Number:
FDA-2013-D-0636
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA published a final rule establishing a unique device identification system (UDI Rule) on September 24, 2013. It requires the labels and device packages of medical devices distributed in the United States include a unique device identifier, unless we grant an exception or alternative to UDI label requirements. The UDI Rule also requires specified product information be submitted to FDA’s Global Unique Device Identification Database (GUDID). This guidance document provides the FDA's recommendations on the information necessary for labelers submitting data to GUDID. FDA has updated this document to reflect changes to the Global Medical Device Nomenclature (GMDN) field in GUDID. The option to use FDA Preferred Terms (FDA PT) Codes will be removed because FDA PT codes are no longer necessary since GMDN Terms are now available without a paid membership.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0636.

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