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 an identifier.
The public can access information contained in the GUDID through AccessGUDID.
Under the UDI final rule, the labeler of each medical device labeled with a unique device identifier (UDI) must submit information concerning that device to the GUDID, unless subject to an exception or alternative.
According to the UDI final rule, “The labeler is the person who causes a label to be applied to a device, or who causes the label to be modified, with the intent that the device will be introduced into interstate commerce without any subsequent replacement or modification of the label; in most instances, the labeler would be the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.”
The GUDID contains ONLY the device identifier (DI), which serves as the primary key to obtain device information in the database. Production Identifiers (PI) are not submitted to or stored in the GUDID, but the GUDID will contain production identifier flags to indicate which PI attribute(s) are on the device label.
The GUDID provides two options for submission of device identification information:
- GUDID Web Interface – enables structured input of device information as one DI record at a time.
- HL7 SPL submission – enables submission of device information as xml files
Both submission options require a GUDID account. GUDID device information submission is currently open only to labelers of currently marketed class III medical devices, devices licensed under the Public Health Service Act (PHS Act), and implantable, life-supporting, or life-sustaining devices.
The GUDID is being populated with data about devices according to the compliance timeline in the final rule. GUDID accounts are NOT required for search and retrieval of published information in AccessGUDID, the public portal for GUDID data.
- UDI Formats by FDA-Accredited Issuing Agency - March 9, 2016 (PDF - 246KB)
Global Unique Device Identification Database (GUDID): Data Submission Compliance Date of September 24, 2015 - Guidance for Industry and Food and Drug Administration Staff(PDF - 199KB)
- CDRH Learn with GUDID Overview
- Guidance - Global Unique Device Identification Database (GUDID) - June 27, 2014 (PDF - 2.8MB)
- HL7 SPL Implementation Files – April 14, 2016 (ZIP - 2.4MB)
GUDID Data Elements Reference Table - April 14, 2016(XLS - 174KB) GUDID User Manual -- May 2014(PDF - 2.2MB)
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