GS1 Implementation Guideline for 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 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 healthcare supply chain, from manufacturers to providers.
The purpose of this document is to provide a foundation for the appropriate use of GS1 identification and barcode standards on medical devices within the context of the UDI Rule. This guideline was written primarily for manufacturers/suppliers, but it is relevant to the entire healthcare supply chain (GS1 website, 2 April 2014).
Click here to download the implementation guideline (2.14 MB).

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