The UDI final rule states that information about a device with a UDI must be submitted to the Global Unique Device Identification Database (GUDID). The GUDID is a public database organized by the FDA and will be a reference tool for devices with a UDI. This database will use only the DI (device identifier) portion of the UDI to identify devices.
“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 and HL7 SPL submission – enables submission of device information as xml files.” (FDA) To submit device identification information you must have a GUDID account. In the beginning submissions will be open only “to labelers of currently marketed class III medical devices and devices licensed under the Public Health Service Act.” (FDA)
To request a GUDID account:
– Select one of the submission options available – GUDID Web Interface or HL7 SPL xml file submission.
– Identify the DUNS Number(s) to be used to represent your GUDID account.
– Ensure the organization name and address associated to the DUNS number is correct.
– Identify individuals for the various user roles in GUDID.
– Submit a GUDID New Account Inquiry.
– The FDA UDI Help Desk will email you the GUDID Account Request document.
The public will be able to obtain information from the GUDID. They will be able to search and receive information about a device from a secure web interface or do a system to system search through a web service. Currently the GUDID is not accessible as they are waiting to gather more data.
For more information read the GUDID Guidance.
To read further information from the FDA click here.