Fda Global Unique Device Identification Database Gudid

Regulated product data must be submitted to the global unique device identification database gudid i e. The gudid is a database that aims to improve medical device safety and serve as the. Manufacturers are responsible for submitting and maintaining their own data in the fda s gudid.

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Fda global unique device identification database gudid.

Fda gudid user manual v1 1 i. The draft of this document was issued on september 24 2013. The us fda udi regulatory database. Fda global udi database gudid as part of the udi system the fda is also created the global unique device identification database gudid which include a set of data attributes for each device marked with a udi.

For questions regarding this document contact. Gs1 member organisations across the world will help manufacturers implement with the requirements of the us fda udi regulation to support patient safety and supply chain security. The fda is establishing the unique device identification system to adequately identify devices sold in the u s from manufacturing through distribution to patient use. The gudid contains only the device identifier di which serves as the primary key to obtain information in the database.

The global unique device identification database gudid pronounced good id is a database administered by the fda as part of the udi system. The global unique device identification database gudid contains key device identification information submitted to the fda about medical devices that have unique device identifiers udi. Office of communication outreach and development 1 800 835 4709 or 240 402 7800. Fda designed and developed the global unique device identification database gudid to prepare forthe implementation of the udi final rule.

The gudid contains device identification information submitted by device companies to the fda. The global unique device identification database gudid is a database administered by the fda that will serve as a reference catalog for every device with a unique device identifier udi.