New Version Covers Updated U.S. FDA UDI Guidance, Extensions and Modifications
EWING, NJ – (May 30, 2019) – GS1 US® has published a significant update to its Implementation Guideline, “Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI),” which provides industry best practices for implementing GS1 identification and barcode standards on medical devices within the context of the U.S. Food and Drug Administration’s (FDA’s) UDI Rule. The updated version (R2.0) now reflects new language and context of the regulation since the first Implementation Guideline was published in 2014.
Since passing the U.S. FDA UDI Rule in 2013, the U.S. FDA has issued numerous updates and clarifications to help medical device manufacturers understand how to meet the requirements. These include U.S. FDA Draft Guidance, Final Guidance and extensions or modifications to certain aspects of the rule, such as direct marking of devices, enforcement policy on National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers assigned to devices and form and content of the unique device identifier, among others.
Accordingly, the updated Implementation Guideline developed by GS1 Healthcare US® – an industry group focused on helping improve patient safety and supply chain efficiency through the adoption of GS1 Standards – includes instructions for using GS1 Standards to assist in meeting some requirements of the U.S. FDA UDI Rule, including:
- Device Identifier – GS1 Global Trade Item Number® (GTIN®)
- Production Identifiers (PIs) – GS1 Application Identifiers (AIs)
- Representation of UDI in GS1 barcodes and human readable plain text format
- Direct marking UDI on devices – GS1 rules for permanently marked items
- Global Unique Device Identification Database (GUDID) submission – GS1 Global Data Synchronization Network™ (GDSN®)
"The U.S. FDA UDI Rule establishes important standards for medical device identification that will bring about continuous improvements in the healthcare supply chain and ultimately help increase patient safety,” said Angela Fernandez, vice president of community engagement, GS1 US. “Companies that are just getting started with their UDI implementation program will find this guideline to be an invaluable resource for informing their process, and companies that already have UDI programs underway will benefit from the updated guidance covering all of the developments and changes that have occurred since the rule was first enacted.”
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.
To download the “Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI)” Guideline, visit www.gs1us.org/UDIguide. For more information about GS1 US, visit www.gs1us.org.
About GS1 Healthcare US
GS1 Healthcare US® is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to help improve patient safety and supply chain efficiency. GS1 Healthcare US brings together members from all segments of the healthcare industry to address the supply chain issues that most impact healthcare in the United States. Facilitated by GS1 US, GS1 Healthcare US is one of more than 30 local GS1 Healthcare user groups around the world that support the adoption and implementation of global standards developed by GS1. For more information, visit www.gs1us.org/healthcare.
About GS1 US
GS1 US®, a member of GS1® global, is a not-for-profit information standards organization that facilitates industry collaboration to help improve supply chain visibility and efficiency through the use of GS1 Standards, the most widely-used supply chain standards system in the world. Nearly 300,000 businesses in 25 industries rely on GS1 US for trading-partner collaboration that optimizes their supply chains, drives cost performance and revenue growth while also enabling regulatory compliance. They achieve these benefits through solutions based on GS1 global unique numbering and identification systems, barcodes, Electronic Product Code (EPC®)-based RFID, data synchronization, and electronic information exchange. GS1 US also manages the United Nations Standard Products and Services Code® (UNSPSC®).
Disclaimer: The Guideline titled, “Applying the GS1 System of Standards for U.S. FDA Unique Device Identification (UDI),” has not been reviewed by the U.S. FDA.