GS1 Healthcare US Issues UDI Implementation Guideline
By: GS1 Healthcare US May 02, 2014
GS1 Healthcare US, an industry group formed to promote GS1 standards in the U.S. healthcare industry, has published an implementation guideline for addressing the U.S. Food and Drug Administration’s new regulation for Unique Device Identification (UDI).
Titled “Using the GS1 System for FDA Unique Device Identification (UDI) Requirements,” the guideline is designed for medical-device trading partners, including medical and surgical manufacturers. It is available for free download at www.gs1us.org/udiguide. GS1 was named the first accredited issuing agency for FDA UDI in December, 2013. The UDI rule provides phased implementation deadlines based on risk class. The first deadline of Sept. 24, 2014 applies to manufacturers of Class III devices, and devices listed under the Public Health Services Act. The guideline includes the applicable GS1 Standards, including the GTIN, GS1 data carriers, GS1 application identifiers, direct part marking and the Global Data Synchronization Network (GDSN). It provides detailed guidance on how to implement those standards in the context of the UDI regulation.