FDA Names GS1 First Accredited Issuing Agency for UDIs

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

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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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