LexisNexis Reed Tech

Webinars

Stay ahead with LexisNexis Reed Tech webinars on Pharmaceutical & Medical Device regulations.

ON DEMAND WEBINAR

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

Watch our on-demand webinar to learn about the FDA’s recent updates impacting medical device manufacturers, specifically regarding the Global Medical Device Nomenclature (GMDN) Codes in the Global Unique Device Identification Database (GUDID). With the FDA phasing out Preferred Terms (PTs) by December 17, 2024, and working to eliminate outdated GMDN Codes, manufacturers need to take immediate action to ensure compliance.

Despite previous FDA guidance, over 193,000 GUDID records still contain obsolete GMDN Codes as of January 15, 2025. Manufacturers who have yet to update these records face 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 for replacing 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 Reed Tech’s 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 does this apply 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. Join our expert-led webinar to ensure your medical devices remain compliant with FDA GMDN requirements.

For a customized demonstration: [email protected]+1-215-557-3010

Learn more about our panelists below.

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Panelist

Gary Saner

Gary Saner is a Sr. Manager of Information Solutions in the Reed Tech 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 Reed Tech 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.