MASSDEVICE ON CALL — FDA regulators appointed Belgium’s GS1 to manage its medical device Unique Device Identifier program, issuing IUDs and helping manufacturers keep up with requirements of the program.
GS1 is a not-for-profit global organization that develops and maintains what is says are the "most widely used supply chain standards in the world," affecting a variety of industries and incorporating voices from business, government, communities and other partners.
"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," GS1 U.S. industry engagement senior vice president Siobhan O’Bara said in prepared remarks. "Using GS1 Standards, healthcare organizations around the world are able to uniquely identify and locate medical devices from product conception through every step of the supply chain life-cycle, improving product movement visibility and patient safety."
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