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

Unique Identification of Medical Devices

Learn how GS1 Standards can help your company

The U.S. FDA Unique Device Identification (UDI) Rule* establishes a unique device identification system for medical devices. Under the rule, medical devices will be marked with a Unique Device Identifier (UDI) that will appear on the label and package of a device. UDIs will be presented on device labels in both a human-readable format and a machine-readable format (e.g., a barcode).

GS1 Standards can be used to support your UDI implementation for all Classes of medical devices.

GS1 Standards for U.S. FDA UDI Certificate Course

Avoid common mistakes and receive guidance with the GS1 Standards for the U.S. FDA UDI Online Certificate Course

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Modernize Your Supply Chain

implementation guideline

Implementation Guideline

Learn how to implement GS1 Standards to meet certain aspects of the U.S. FDA UDI Rule.

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quick start guide

Quick Start Guide

Designed for Medical Device Labelers implementing U.S. FDA UDI requirements

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learn from industry

Learn from Industry Leaders

Read how companies have implemented GS1 Standards

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UDI Education

Education and Helpful Tips

Learn about our certificate courses and other education opportunities

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implementation support

Implementation Support

Customized support to help improve operations and enhance quality of care

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Resources for Healthcare Providers

Are you a Healthcare Provider and looking for education and implementation resources? If so, please visit www.gs1us.org/HealthcareProviders to learn how GS1 Standards can help your organization modernize its supply chain, improve patient safety, and reduce costs.

*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.