GS1 Named First FDA-Accredited UDI Issuing Agency

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Lawrenceville, N.J.-based GS1 US was named the first accrediting issuing agency for unique device identifiers by the U.S. Food and Drug Administration, according to a news release.

The issuing agency's GS1 Standards provide identification and information for healthcare products, assets, services and locations. Several GS1 Standards are already in use in the healthcare industry, such as the Global Trade Item Number, and are now approved as FDA-compliant UDIs.  

In September, the FDA released a final rule requiring medical devices to be labeled with accredited UDIs.


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