Global UDI Database (GUDID)
The Global Unique Device Identification Database (GUDID) is a publicly searchable database administered by the FDA that will serve as a reference catalog for every device with an identifier. 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 will initially be open only to labelers of currently marketed class III medical devices and devices licensed under the Public Health Service Act (PHS Act).
The public will have access to information contained in the GUDID. There will be two information retrieval options for published DI information:
- Search and retrieval of device information via secure web interface
- System to system search and retrieval via web service (download capability is planned for the future)
The GUDID will be populated with data about devices according to the compliance timeline in the final rule. However, the public GUDID search function is temporarily disabled until a meaningful dataset of DI records has been created. GUDID accounts will NOT be required for search and retrieval of published information.
- CDRH Learn with GUDID Overview
- Guidance - Global Unique Device Identification Database (GUDID) - June 27, 2014 (PDF - 2.8MB)
- HL7 SPL Implementation Files (ZIP - 1.5MB)
FDA Webinar: Global Unique Device Identification Database (GUDID) Account Set Up GUDID Data Elements Reference Table - May 7, 2014(XLS - 91KB) UDI Formats by FDA-Accredited Issuing Agency May 7, 2014(DOC - 132KB) GUDID User Manual -- May 2014(PDF - 2.2MB)