GS1 Recognized as Accredited Issuing Agency for Unique Device Identification
FDA has accredited global standards organization GS1 as an issuing agency for unique device identifiers under the agency's Unique Device Identification (UDI) rule, which was published in September 2013. The regulation requires all UDI numbers to be assigned by an FDA-accredited issuing agency.
“Global GS1 Standards support the FDA’s vision for a harmonized global supply chain, which is increasingly important as healthcare products are manufactured, shipped and sold across borders,” stated Siobhan O’Bara, senior vice president, industry engagement, GS1 US, in a press release. “Using GS1 Standards, healthcare organizations around the world are able to uniquely identify and locate medical devices through every step of the product lifecycle, improving supply chain visibility and patient safety.”
A UDI number generally must be applied to the medical device label, its packaging, and, in some cases, the device itself, GS1 explains. GS1 Standards, including the Global Trade Item Number (GTIN), are already in use by leading healthcare manufacturers and are accepted across the U.S. healthcare industry as a unique identifier of medical/surgical products for every level of packaging, it was reported in the release.
GS1 US has developed a UDI Resource Website (www.gs1us.org/hcudi) that provides information on how GS1 Standards can help meet UDI requirements, perspectives from GS1 US experts, steps to get started, FAQs, and guidance on GTIN implementation.
For more information about GS1 US, visit www.gs1us.org.