GUDID Availability for Class 2 Labelers

Beginning February 1, 2016, FDA will accept GUDID account requests from labelers of Class 2 devices. These labelers should set up a GUDID account as soon as possible to allow adequate time for system compatibility testing and data submission. FDA expects a large submission volume in 2016 because of the number of Class 2 devices. The compliance date for Class 2 labels, packages, date format, and GUDID submissions is September 24, 2016.