FDA Issues Updated Guidance on the Global Unique Device Identification Database (GUDID)

On December 17, 2024, the US Food and Drug Administration (FDA) issued a revised final guidance for the Global Unique Device Identification Database (GUDID), replacing the 2014 edition. This updated guidance introduces key changes to enhance compliance with Unique Device Identification (UDI) regulations, streamline submission processes, and improve data quality for medical device manufacturers.

One of the most notable updates is the elimination of references to FDA Preferred Term Codes (PT). This adjustment follows the Global Medical Device Nomenclature (GMDN) Terms becoming freely accessible, establishing them as the mandatory standard for device identification. By transitioning to GMDN codes, the FDA aims to promote global harmonization and simplify the classification and registration process for manufacturers.

In addition to this nomenclature shift, the revised guidance includes enhanced validation rules and a more intuitive user interface for GUDID submissions. These improvements are designed to reduce errors, optimize workflows, and support manufacturers in submitting accurate and compliant data. Together, these updates represent a step forward in creating a more robust and efficient system for device identification and tracking.

For medical device manufacturers, this guidance marks a critical evolution in regulatory clarity and operational efficiency. Accurate device identification is not only essential for compliance with US regulations but also a cornerstone of global market access strategies. As the regulatory landscape continues to evolve, staying ahead of these changes is imperative for ensuring seamless operations and maintaining competitiveness.