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Global UDI Database (GUDID)

 The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every device with an identifier. Under the UDI final rule, the labeler of each medical device labeled with a unique device identifier (UDI) must submit information concerning that device to the GUDID, unless subject to an exception or alternative.

FDA has accredited three organizations as UDI issuing agencies: GS1, Health Industry Business Communications Council (HIBCC), and International Council for Commonality in Blood Banking Automation (ICCBBA). Each issuing agency has a unique device identifier (UDI) format that was reviewed and approved by FDA as part of its process for accrediting issuing agencies. Any changes to the format of the UDI by an issuing agency must be approved by the FDA before implementation.

Compliance Mandates

Data for all of UDI devices must be approved by the GUDID database.

 

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