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

The FDA's updated guidance for the Global Unique Device Identification Database (GUDID) introduces essential changes for medical device manufacturers. Released on December 17, 2024, this revised guidance replaces the 2014 version, focusing on compliance with UDI regulations and enhancing the submission process. Key updates include the shift to GMDN codes as the standard for device identification, ensuring global harmonization and simplifying classification and registration. Additional improvements feature enhanced validation rules and a streamlined user interface for GUDID submissions, minimizing errors and optimizing workflows. This guidance strengthens the system for device tracking, crucial for regulatory compliance and global market access strategies. Staying aligned with these changes is critical for manufacturers to ensure seamless operations and maintain a competitive edge.