Food and Drug Administration (FDA) medical device regulators have issued new recommendations to United States (US) market registrants ahead of new enhancements to their database of Unique Device Identification (UDI) information. The FDA has stated that, as part of an upcoming launch of the Global Unique Device Identification Database (GUDID Release 2.3), components of UDI information including premarket submission numbers and supplement numbers will be released to the public in summer 2018.
The FDA recommends that medical device registrants should familiarise themselves with FDA’s plans to determine whether premarket submission numbers are releasable and make sure that their GUDID records contain all necessary listing numbers, ahead of GUDID Release 2.3. Furthermore registrants are advised to review confidentiality designations assigned to their device proprietary names entered into the GUDID Device Registration and Listing Module (DRLM).
In May 2018, the FDA plans to implement GUDID Release 2.3 releasability logic and begin the review period whereby registrants should review whether their premarket submission and supplement numbers will become publically available as part of their Device Identification Data (DI) record information. If registrants need to make any changes to their information after the review then it is recommended that they update the Proprietary Brand Name Confidentiality Flag in DRLM. The FDA plans to begin releasing premarket submission and supplement numbers in June 2018 via AccessGUDID and OpenFDA websites.
To view the FDA’s communication notice to medical device registrants with regards to the upcoming launch of GUDID Release 2.3, please click here.