FDA Finalizes Medical Device ID Database Guidance

The Food and Drug Administration recently released finalized guidance for medical device labelers for submitting data to the Global Unique Device Identification Database.

A draft version of the guidance was originally released in Sept. 2013.

According to an AHANewsNow report, a 2013 final rule mandates many device labels and packages to have a unique device identifier, and device manufacturers have to submit information to the GUDID. Hospitals that reprocess single-use devices may be subject to that rule, which is being phased in over six years.

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