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.