Global Unique Device Identification Database
- Outline 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 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.
- Compliance Dates for UDI Requirements
- Creating GUDID
3.1 Preparing GUDID
Familiarize yourself with the two submission options available – GUDID Web Interface and HL7 SPL xml file submission.
Identify the DUNS Numbers to be used for your GUDID account.
Ensure the company name and address associated to the DUNS number is correct; if any changes are necessary, please update your information in the D&B DUNS database before requesting a GUDID account.
Identify individuals for the various user roles in GUDID — Regulatory Contact, Coordinator(s) and LDE user(s).
Identify an individual to request the GUDID account; and, once the account is established, to manage all account changes.
Identify third-party submitters, if applicable.
3.2 GUDID Account Request Process
The following information should be provided when requesting a GUDID Account:
Labeler Organization DUNS Number – this DUNS number represents the labeler’s view of the highest corporate level in the labeler organization; it may be the headquarters DUNS number, or the parent DUNS number for the Labelers included in the GUDID account.
Labeler Organization Name – this is used for verification purposes only; GUDID obtains company name and address from the D&B DUNS database.
Regulatory Contact information – name, email, phone, physical address.
Labeler DUNS for the GUDID Account – as indicated earlier in Section 3.1.1, the company name associated to the Labeler DUNS number should match the labeler name as it appears on the device label; ideally, the company address associated to the DUNS number should also match the address on the label, but since address is not displayed to the GUDID public user, this is not a requirement for data consistency.
Third-party DUNS numbers, if applicable
Indicate the preferred submission option – Web Interface or HL7 SPL or both
Each GUDID account will have, at a minimum:
one Regulatory Contact
one Labeler DUNS number
one Coordinator – for submitters who are using the HL7 SPL submission option, the Coordinator user is optional.
Once a GUDID account is created:
The Web Interface submitter may login and begin using GUDID.
HL7 SPL ONLY submitters shall
Establish a GUDID account.
Use the FDA ESG to submit HL7 SPL files.
Once GUDID and ESG accounts are established, companies would be required to complete GUDID testing prior to production submissions. Detailed information on testing requirements/process is available as part of the GUDID HL7 SPL Implementation Files on http://www.fda.gov/udi
Companies may choose to use third-party submitters to submit device information on their behalf.
3.3 GUDID Account Changes
Account changes may include:
Update Regulatory Contact information
Add/update Coordinator information
Change assignment of Labeler DUNS to Coordinators
Add Labeler DUNS
Add/update third-party submitter information
Account changes related to mergers/acquisitions that may impact DI records – current version of GUDID has not implemented capability to handle all use-cases surrounding mergers/acquisitions. We are actively working to identify requirements for future system implementation. We request that you please contact us if you anticipate a merger/acquisition that may impact your DI records, so we can work proactively to address your situation.
Please Contact us for any further question.