The Global Language of Business

GS1 Accredited as Issuing Agency for Unique Device Identification by the U.S. Food and Drug Administration

GS1 today received accreditation by the U.S. Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDIs). Global GS1 Standards meet the government’s criteria for UDIs and will help manufacturers to address requirements of the new FDA UDI regulation, which was published in September 2013 to support patient safety and supply chain security.

The Unique Device Identification system aims at creating a common worldwide system for product identification that will improve healthcare business processes and patient safety. The U.S. FDA UDI rule is the first to be released but is expected to be followed by other similar regulations worldwide.