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The Global Language of Business

Implementation Guideline – Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI)

This implementation guideline was prepared by GS1 Healthcare US® to assist suppliers and receivers of medical devices in the U.S. to implement the U.S. FDA UDI Rule using GS1 Standards. This guideline is based on the GS1 General Specifications, and was developed using information obtained from all members of the U.S. healthcare supply chain, from manufacturers to providers.*

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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.