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

Meeting the Needs of U.S. FDA UDI Rule

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.

Are you interested in learning how unique device identifier information is being used at point of care? Register for our free webinar with the Veterans Affairs Medical Center on March 28 from 2:00 - 3:00 PM, to learn how they demonstrated the benefits of scanning UDI barcodes on the front lines.


GS1 Standards for U.S. FDA UDI Certificate Course

GS1 Standards for U.S. FDA UDI Online Certificate Course

Learn More >

Sign up for GS1 US industry updates

Get industry information and resources delivered directly to your email inbox. Sign up to receive white papers, standards updates, guidelines, case studies, and more.

*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.