Global Unique Device Identification Database (GUDID)
UPDATE: December 17, 2024
Today, the U.S. Food and Drug Administration (FDA) issued minor updates to this final guidance: Global Unique Device Identification Database (GUDID) - Guidance for Industry and Food and Drug Administration Staff.
This guidance update reflects upcoming changes to the Global Medical Device Nomenclature (GMDN) field in GUDID and other minor clarifications. The FDA will be removing FDA Preferred Term (PT) Codes from GUDID. These are no longer necessary because anyone can now access and use GMDN Codes for free.
The FDA will let users know when the changes to GUDID are implemented. Once the FDA PT Codes are removed, GUDID users will only be able to use GMDN Codes.
The FDA encourages GUDID users to switch from FDA PT Codes to GMDN Codes now using GMDN resources including:
GUDID enhancements to improve user experience, build in better validation rules, and other changes may continue as we receive user feedback. We intend to periodically update this guidance document to reflect system changes and enhancements.
Each Device Identifier (DI) record is subject to GUDID business rules to help ensure data quality. GUDID business rules for each data attribute are provided in the GUDID Data Elements Reference Table.
The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that serves as a reference catalog for every device with a unique device identifier (UDI).
GUDID contains ONLY the device identifier (DI) portion of the UDI, which serves as the key to obtain device information in the database. While GUDID does not include production identifiers (PIs), GUDID contains PI flags to indicate which PI attributes are in the UDI.
The AccessGUDID Database includes the field for Global Medical Device Nomenclature (GMDN) Code along with the status of the GMDN Code, Active or Obsolete.
These fields are available in AccessGUDID and the open FDA Unique Device Identifier endpoint, and are intended to provide the end user with enhanced search and retrieval capabilities for GUDID data.
Resources are available on the GMDN website to help labelers identify appropriate GMDN Term Codes for their products including alternatives to obsolete term codes.
Device Labelers: Submit Data to GUDID
The FDA provides device labelers with two options for submitting data to GUDID: the manual data entry via GUDID web application (for entering data for one device at a time) and HL7 SPL submission via FDA Electronic Submissions Gateway (for bulk uploads). For details on each option, see Submit Data to GUDID.
Search the AccessGUDID Database
AccessGUDID is a searchable database of device identification information, such as the device identifier on the label, device name, company name, MR safety status, Global Medical Device Nomenclature (GMDN) Term, Code, and Status and premarket submission numbers. AccessGUDID is available for anyone, including patients, care givers, health care providers, hospitals, and industry.
GUDID Data Quality
To fully reap the public health benefits and a return on investment of the UDI system, FDA is focusing resources on optimizing the quality and utility of data in the GUDID database, which appears as publicly releasable data in AccessGUDID. FDA is also committed to working with industry to ensure widespread use and sustainability of the UDI system. For details, see Optimizing GUDID Quality.
GUDID Data Trends
Each month, the FDA produces presentation slides summarizing patterns and trends in the GUDID data. These presentation files are available for download. For details, see GUDID Data Trends.