Navigating FDA GMDN Compliance: Replacing FDA Preferred Terms and Updating Obsolete GMDN Codes

FDA GMDN compliance for medical device manufacturers

Watch our on-demand webinar to learn about the FDA’s updates impacting medical device manufacturers, specifically regarding the Global Medical Device Nomenclature (GMDN) Codes in the Global Unique Device Identification Database (GUDID). The FDA phased out Preferred Terms (PTs) as of December 17, 2024, and worked to eliminate outdated GMDN Codes, so manufacturers needed to take immediate action to ensure compliance.

Despite previous FDA guidance, over 193,000 GUDID records still contained obsolete GMDN Codes as of January 15, 2025. Manufacturers who had yet to update these records faced increased regulatory risks and potential enforcement actions.

Key takeaways

Understand the FDA’s GMDN compliance initiatives and their impact on medical device labeling.
Learn the timeline and requirements that replaced FDA Preferred Terms (PTs) with 5-digit GMDN Codes.
Identify how to check for and update obsolete GMDN Codes in the GUDID system.
Discover how LexisNexis Life Sciences’ professional services can assist in identifying and replacing non-compliant codes efficiently.
Gain insights into best practices for ensuring long-term compliance and avoiding last-minute updates.

Who this applies to

Global Strategy Business Managers
Regulatory Affairs/Operation Leaders
Product Managers and Business Analysts
Manufacturing, Operations, and Supply Chain Leaders
Quality Leaders
IT Support

Stay ahead of compliance deadlines and avoid regulatory setbacks. Watch our expert-led webinar to ensure your medical devices remain compliant with FDA GMDN requirements.

Learn more about our panelist below.

Panelist

Gary Saner is a Sr. Manager of Information Solutions in the LexisNexis Life Sciences group. He is a subject matter expert on Drug Labeling, Medical Device UDI, and other structured content reporting to regulatory agencies and commercial organizations. He has over 40 years of experience in software development, process management, and data administration, with the last 19 years focused on the Life Sciences industry. With a deep understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at LexisNexis Life Sciences for data management, validation, processing, and submission of Drug Labeling content, Cosmetic information, and Medical Device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team.

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