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US FDA Preps Enhancements to Global Unique Device Identification Database (GUDID)

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EMERGO SUMMARY OF KEY POINTS:

  • US FDA will release Global Unique Device Identification Database (GUDID) information including premarket submission and supplement numbers to the public in summer 2018.
  • Medical device registrants should familiarize themselves with FDA plans and review their own confidentiality designations immediately.
  • FDA will begin releasing GUDID data to the public in June 2018.

FDA GUDID data publically released in summer 2018US FDA medical device regulators have issued new recommendations to US market registrants ahead of new enhancements to their database of Unique Device Identification (UDI) information.

In a recent communication to medical device registrants, the agency explained 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 publically released in summer 2018.

Immediate GUDID preparations recommended

Ahead of GUDID Release 2.3, the agency recommends that medical device registrants familiarize themselves with FDA’s plan to determine whether premarket submission numbers are releasable; make sure that their GUDID records contain all necessary listing numbers; and review confidentiality designations assigned to their device proprietary names entered into the GUDID Device Registration and Listing Module, or DLRM.

FDA also plans to allow registrants to review their premarket submission numbers before those numbers are made public.

GUDID enhancement timeframes

The agency has set a May 2018 timeframe for implementing GUDID Release 2.3 releasability logic and beginning the review period whereby registrants should review whether their premarket submission and supplement numbers will become publically available as part of their Device Identification (DI) data.

Registrants that need to make changes to their information after review should update the Proprietary Brand Name Confidentiality Flag component of their DLRM.

Then, FDA will begin releasing premarket submission and supplement numbers in June 2018 via AccessGUDID and OpenFDA websites.

Related US FDA UDI regulatory resources from Emergo:

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