USFDA Guidance: Global Unique Device Identification Database (GUDID): Enhancing Medical Device Transparency

The U.S. Food and Drug Administration (FDA) has updated and released its "Global Unique Device Identification Database (GUDID)" final guidance to provide essential instructions for medical device labelers and stakeholders.

This guidance highlights the mechanisms for ensuring the accurate identification and traceability of medical devices, leveraging global standards and a centralized database. This guidance is primarily intended for device labelers1 and provides information necessary for submitting data to the Global Unique Device Identification Database (GUDID).

The “unique device identifier” (UDI) should be created and maintained by device labelers based on global device identification standards managed by FDA-accredited Issuing Agencies.

The Global Unique Device Identification Database (GUDID) is a centralized repository designed to store critical identification information for medical devices. This database is a cornerstone of the FDA’s Unique Device Identification (UDI) system, which assigns every medical device a unique identifier to enhance traceability and patient safety.

Key Features of GUDID

1. Unique Device Identifier (UDI): A UDI consists of:

   • Device Identifier (DI): A fixed portion that identifies the device's version or model.

   • Production Identifier (PI): A variable portion that can include details like lot number, serial number, or expiration date.

   The UDI must appear on medical device labels unless exempted, ensuring global alignment and traceability.

2. Database Functionality:

   • GUDID serves as a repository for critical device identification data.

   • It facilitates public access to device information, fostering transparency.

   • Labelers must submit DI records before introducing devices into commercial distribution.

3. GUDID Submission Options:

   • Web Interface: Ideal for low-volume submissions, requiring manual data entry.

   • Health Level 7 Structured Product Labeling (HL7 SPL): Suitable for high-volume submissions via XML files.

4. Global Medical Device Nomenclature (GMDN):

   • Standardized descriptors are required for DI records.

   • Labelers must use active GMDN terms, reflecting updates and regulatory nuances.

GUDID plays a pivotal role in advancing patient safety and regulatory oversight. By providing a standardized mechanism for identifying devices, it:

• Enhances supply chain visibility.

• Aids in post-market surveillance and adverse event reporting.

• Ensures compliance with global regulatory frameworks.

The guidance emphasizes adherence to 21 CFR 830.330, ensuring timely updates to DI records and alignment with FDA regulations. It also provides a framework for addressing data inconsistencies, mergers, or acquisitions affecting DI records. For more detailed information, refer to the FDA's official guidance document here.