Fda Global Unique Device Identification Database

On june 26 2014 fda issued the global unique device identification database gudid.

Fda global unique device identification database.

Over the past year fda designed and developed the global unique device identification database gudid to prepare forthe implementation of the udi final rule. A draft version of this. The unique device identifier udi should be created and maintained by device labelers based on global device identification standards managed by fda accredited issuing agencies 2 3. 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.

This document is primarily intended for device labelers and provides information necessary for submitting data to the global unique device identification database gudid. Guidance for industry this guidance describes key gudid concepts such as account management user roles the. The fda udi help desk will email you the gudid new account request document in a fillable pdf format. Proposed rule requiring most medical devices distributed in the united states to carry a udi.

Prepare for 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. Fda established a set of compliance dates by device classification for compliance with required labeling and data submission to the global unique device identification database gudid under the.