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FDA Updates its Global Unique Device Identification Database

February 21, 2018

The FDA issued updates on its Global Unique Device Identification Database (GUDID) which will go into effect in late March followed by additional enhancements in late summer 2018.

In March, UDI labelers will have the ability to unlock their device identification records after the grace period to make error corrections.

In summer 2018, FDA will release premarket submission and supplement numbers into the database.

GUDID updates include new file data elements, record accessibility, and premarket submission and supplement number requirements.

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