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 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 Certificate Course

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