Implementation Guideline for U.S. FDA Unique Device Identification (UDI)

This guidance document is currently under review, please check back at the end October 2018 for the updated implementation guide.

For additional U.S. FDA UDI resources, please visit our resource page.*

*For information about the rule, see the U.S. FDA Unique Device Identification System 

Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.

GS1 is a U.S. FDA-Accredited Issuing Agency for UDI, and GS1 Standards are authorized for use in implementing the requirements of the U.S. FDA UDI Rule.