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FDA To Issue UDI Database Draft Guidance In March

The draft guidance will serve as a user’s guide to the soon-to-be-released unique device identifier database, providing definitions for the device elements and attributes that companies have to submit to the database.

FDA’s device center will issue a draft guidance document next month to assist companies in using soon-to-be-released global unique device identifier database.

The global UDI database is an integral component of CDRH’s developing UDI program, which was outlined in a proposed rule issued last September, requiring device manufacturers to include a unique...

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