GS1 Standards Resources for U.S. FDA UDI Implementation Support

The U.S. FDA UDI Rule establishes a unique device identification system for medical devices. Under the rule, medical devices will be marked with a unique device identifier 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). Re-usable devices that need to be “reprocessed” before reuse will also be directly marked with a UDI. In addition, device labelers will submit device information to a U.S. FDA database called the Global Unique Device Identification Database (GUDID).*

Resources to help you on your journey

Implementation Guideline - Using the GS1 System for U.S. FDA Unique Device Identification (UDI) Requirements - to help you implement GS1 Standards to meet certain aspects of the U.S. FDA UDI Rule. 

FAQs - U.S. FDA UDI Rule Frequently Asked Questions - get answers to frequently asked implementation questions

Infographic – GS1 Standards at a Glance in Healthcare – get a single view of the GS1 Identify, Capture, and Share Standards in Healthcare, including key terms and their definitions.

Case Study – Siemens Healthineers takes UDI implementation to next level for its digital transformation - learn how they use the GS1 System to create a strategic foundation of quality data.

Barcode Chart – this barcode cheat sheet provides a subset list of the most common barcode types and their functions.

GTIN Adoption and Usage Model - Implementation Roadmap for U.S. Healthcare Supply Chain – view this self-assessment tool to gauge your organization’s progress in adopting and using the Global Trade Item Number®. This document helps healthcare companies improve patient safety and supply chain efficiency by better leveraging unique product identification.

Medical Device Labeler U.S. FDA UDI Quick Start Guide - to help you get started in implementing GS1 Standards for the U.S. FDA UDI Rule.  

Standards Guidance for Assigning DIs Using Global Trade Item Numbers (GTINs)

Infographic - Quick Reference Guide to GS1 Identifiers & Barcodes for U.S. FDA UDI

Medical Device Brand Owner Guide - Transitioning to GS1 Standards in the U.S. for FDA UDI - to assist brand owners, who have previously followed a different identification and marking standard for products, in their migration to GS1 Standards for identification and barcoding in the healthcare supply chain and support the U.S. FDA UDI Rule.

Implementation Guide - Leveraging the Global Data Synchronization Network (GDSN®) for the U.S. FDA Global Unique Device Identifier Database (GUDID)

Guide - GS1 US Data Hub® | Product Unique Device Identification (UDI) Creation - to guide you in using the automated Data Hub tool to assign GTIN DIs and create barcodes with DI and production identifiers.

Creating New Reimbursement Numbers for Medical Devices – this process outlines a temporary solution for manufacturers who are required to establish a new reimbursement number for a device sold through a pharmacy and that are potentially eligible for reimbursement. 

Executive Brief - Medical Device Supplier - reduce costs and meet customer requirements. Learn how adopting the GS1 Standards can help your organization address current needs and better prepare for future challenges -- by enabling seamless integration of product and customer information across internal business systems and with trading partners.

Certificate and Customized Education

Are you continuing your Class III or Class II implementation or preparing for Class I? These certificate courses provide the most comprehensive training we offer to help you with using GS1 Standards for your UDI implementation.

Gain a deep understanding of GS1 identification, barcode, and data standards that can be used to implement UDI Rule requirements for product identification, product labeling, and submission of product information to the GUDID.

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

Take this course to gain a deep understanding of GS1 identification, barcode, and data standards that can be used to implement UDI Rule requirements.

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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.