FDA Posts Guidance on Database for Medical Device UDIs
The Food and Drug Administration on June 11 finalized parts of a new guidance on its database for medical device unique identifiers. The guidance includes information for device labelers (in most instances, the device manufacturer) on how to use the…
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Global Unique Device Identifier Database (GUDID), including how to establish GUDID accounts and begin initial submissions. Labelers are required to submit data to GUDID if a device must be labeled with a Unique Device Identifier (UDI), FDA said in its final regulations on the subject. Many parts of FDA’s guidance on GUDID have not been finalized, and have been left blank until they are, said FDA in a concurrent Federal Register notice (here).