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Fda global unique device identification database gudid. 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. Manufacturers are responsible for submitting and maintaining their own data in the fda s gudid. Global unique device identification database gudid guidance for industry. 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.
The draft of this document was issued on september 24 2013. The gudid contains only the device identifier di which serves as the primary key to obtain information in the database. Fda designed and developed the global unique device identification database gudid to prepare forthe implementation of the udi final rule. 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.
Regulated product data must be submitted to the global unique device identification database gudid i e. The gudid contains device identification information submitted by device companies to the fda. The gudid is a database that aims to improve medical device safety and serve as the. The global unique device identification database gudid pronounced good id is a database administered by the fda as part of the udi system.
For questions regarding this document contact. The us fda udi regulatory database.
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