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USFDA issues final guidance on Global Unique Device Identification Database (GUDID)

bio_subbu

bio_subbu

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Dear All

The US Food and Drug Administration (FDA) has issued final guidance titled “Global Unique Device Identification Database (GUDID)” on 27th June 2014. This document is primarily intended for device Labelers, and provides information necessary for submitting data to the Global Unique Device Identification Database (GUDID). A draft version of this document was released on 24 September 2013 with a 60 day comment period, which ended on 25 November 2013, more than 300 comments were received from 21 entities. In order to provide labelers access to the latest information as soon as it is available, and address sections that received the most comments and questions, sections of this document were previously finalized and released on 11th June 2014. This current iteration of the document finalizes the remaining sections and incorporates sections finalized earlier, in order to provide one complete and final document.

Please refer below links to access the “final” guidance document & FDA’s Federal Register notice.

http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM369248.pdf

http://www.gpo.gov/fdsys/pkg/FR-2014-06-27/html/2014-15020.htm
 

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