GS1 Named First FDA-Accredited UDI Issuing Agency

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.


More Articles on the FDA:


FDA, European Medicines Agency to Collaborate on Generic Drug Approvals
FDA, CMS Extend Parallel Review Program
FDA Updates Medical Device Recalls Database

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Whitepapers