Image: GS1 US U.S. FDA UDI Rule Education and Implementation Resources

Meeting the Needs of U.S. FDA UDI Rule

Learn how your company can support UDI requirements with GS1 Standards

The U.S. FDA UDI rule on the establishment of a Unique Device Identification System requires that medical devices distributed in the U.S. must now carry a Unique Device Identifier (UDI), with some exceptions. This system will provide a standardized way to identify devices across all information sources and systems, including electronic health records and device registries.*

Global GS1 Standards, administered in the U.S. by GS1 US®, are authorized for use by manufacturers to address requirements of the new U.S. FDA UDI regulation. As GS1 is a U.S. FDA-Accredited Issuing Agency, GS1 US can help your company address U.S. FDA UDI requirements with proven product identification and barcoding standards used by over two million companies worldwide.


GS1 Standards for U.S. FDA UDI Certificate Course

GS1 Standards for U.S. FDA UDI Online Certificate Course

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*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.