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.
On August 14, 2023 the fields released in the public AccessGUDID Database and the openFDA Unique Device Identifier endpoint will be updated to include Global Medical Device Nomenclature (GMDN) Term Codes and will include the status of the GMDN Term Code, Active or Obsolete. If a labeler submitted an FDA Preferred Term (FDA PT) Code to meet their GMDN Code data entry requirement, the equivalent GMDN Code will now also be released publicly. This latest update is intended to provide the end user with enhanced search and retrieval capabilities for GUDID data.
To prepare for the release of the field for Global Medical Device Nomenclature (GMDN) Term Code along with the status of the GMDN Term Code, Active or Obsolete, in AccessGUDID, labelers should review their GUDID entries to assure they are using accurate, active, non-obsolete GMDN Term Codes or FDA PT Codes. Labelers are required to update the information they have submitted to GUDID in 21 CFR 830.330(b). The FDA expects labelers to complete their updates within the timelines specified in the regulations and by the end of July 2023 to assure that accurate information is released publicly when this field is released on AccessGUDID and openFDA. Resources are available on the GMDNExternal Link Disclaimer website to help labelers identify alternatives to the 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, 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.