Understanding GUDID: A Guide to the Global Unique Device Identification Database for Medical Device Labelers

The Global Unique Device Identification Database (GUDID) is the cornerstone of the FDA's Unique Device Identification (UDI) system. It provides a single, authoritative source of device information that regulators, healthcare providers, researchers, and patients can all access.

For a medical device labeler, understanding GUDID is essential not just for compliance but also for ensuring your devices are trusted and traceable throughout their lifecycle.

What is GUDID?

The GUDID is an FDA-managed database that stores identifying information about medical devices sold in the U.S. It does not contain confidential design or performance details but only standardized attributes that describe the device.

Each GUDID record includes:

• Device Identifier (DI): The fixed part of the UDI that identifies the labeler and device version/model.
• Device attributes: Device name, version, brand, catalog number.
• FDA product code and GMDN term (standardized nomenclature).
• Packaging information: including package configurations.
• Production Identifier (PI) flags: an indication of whether lot numbers, serial numbers, expiration dates, or manufacture dates appear on the label.
• Direct marking details (if the device has a permanent UDI marking).

Important:

The database does not store actual PI values (like individual serial numbers or batch codes). It only shows whether they are part of the label.

The GUDID supports transparency and traceability of medical devices, while ensuring standardization and global alignment.

How is a UDI Assigned?

A UDI is made up of two parts:

1. Device Identifier (DI) – fixed, required, identifies the labeler and specific device version/model.

2. Production Identifier (PI) – variable, conditional, includes lot/batch numbers, expiration dates, or serial numbers.

UDIs can only be issued through FDA-accredited issuing agencies such as GS1, Health Industry Business Communications Council (HIBCC), or International Council for Commonality in Blood Banking Automation (ICCBBA).

Steps Labelers Must Follow:

1. Preparation

Before requesting a GUDID account:

• • Obtain and verify a DUNS number (Dun & Bradstreet).
  • Identify key user roles:
  • Regulatory Contact – official responsible for compliance. Coordinator – manages account and user setup.
  • Labeler Data Entry (LDE) User – enters device data.
  • Decide whether a third-party submitter will assist. Even if a third-party submits data on your behalf, the labeler remains legally responsible for the accuracy and completeness of GUDID submissions.

2. Request a GUDID Account

   Submit an account request to the FDA. Each account is tied to your labeler’s DUNS number.

   • Provide Regulatory Contact and Coordinator details.

   • Indicate your preferred submission method

     Web Interface (manual entry, for low volume), or

     HL7 SPL via FDA ESG (XML file submissions, for high volume).

   Once approved, the FDA provides login credentials.

3. Create and Manage DI Record

   • Each device version/model requires a Device Identifier (DI) Record in GUDID.

   • DI records can be in three states:
     Draft – editable, not yet validated.
     Unpublished – validated, scheduled for a future publish date. Published – live in GUDID and searchable by the public.

4. Maintain Accuracy Over Time

   • Once a record is published. Labelers must:
     Keep DI records updated throughout the total product lifecycle.
     Update within 10 business days if information changes (e.g., GMDN term becomes obsolete).
     Respect editing rules: after a 7-day Grace Period, only limited edits are allowed; some changes require a new DI.

Summary

The GUDID is not just a regulatory system, it is a foundation for safer, more transparent healthcare. By assigning UDIs correctly and maintaining accurate device records, labelers play a critical role in ensuring that devices are identifiable, traceable, and trustworthy across their entire lifecycle.