FDA has announced plans to grant the public access to the data in the “FDA Premarket Submission Number” and “Supplement Number” fields (premarket numbers) in the GUDID Device Identifier (DI). This data is tentatively scheduled to be made public on July 2, 2018. FDA recognizes that this information may be sensitive and will give labelers the option of keeping their premarket numbers confidential. Specifically, FDA will use the confidentiality information that is included in the device listing information submitted to the FDA Unified Registration and Listing System/ Device Registration and Listing Module (FURLS/DRLM). If a proprietary name is marked confidential in DRLM as part of the device listing information, then FDA does not plan to make the corresponding premarket numbers in GUDID DI record(s) public.
Labelers who would prefer to keep the their premarket numbers confidential may find it advisable to carefully scrutinize and potentially alter the confidentiality designations assigned to the DRLM proprietary names in their device listing records in order to ensure that these designations correspond to their preferences.
