Navigating FDA GMDN Compliance

The FDA has introduced significant updates impacting medical device manufacturers, specifically targeting the Global Medical Device Nomenclature (GMDN) Codes in the Global Unique Device Identification Database (GUDID). With the deprecation of FDA Preferred Terms (PTs) as of December 17, 2024, and an ongoing initiative to eliminate obsolete GMDN Codes, manufacturers must 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 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. View our expert-led webinar to ensure your medical devices remain compliant with FDA GMDN requirements.

For a customized demonstration: MedDevice@ReedTech.com, +1-215-557-3010

Learn more about our panelists below.

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.

LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.

For more information, please visit ReedTech.com.

Life Sciences Solutions Driven by Accuracy and Insight
Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry's data. Our offerings smooth the collection, transformation, submission, and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.

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

Watch Now
Navigating FDA GMDN Compliance:

Replacing FDA Preferred Terms and Updating Obsolete GMDN Codes

Key Takeaways:

Panelists:

Let's talk

Medical Device Solutions

Pharmaceutical Solutions

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

Watch NowNavigating FDA GMDN Compliance:

Replacing FDA Preferred Terms and Updating Obsolete GMDN Codes

Key Takeaways:

Panelists:

Let's talk

Medical Device Solutions

Pharmaceutical Solutions

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

Watch Now
Navigating FDA GMDN Compliance: