The FDA has introduced significant updates impacting the medical device industry, specifically targeting Global Medical Device Nomenclature (GMDN) Codes compliance in the Global Unique Device Identification Database (GUDID). These changes aim to improve standardization and ensure accurate device classification. Below, we summarize the latest developments and outline how LexisNexis Reed Tech can support manufacturers in achieving compliance.
FDA Preferred Terms (PT) Replacement Initiative
Effective December 17, 2024, the FDA deprecated the use of 4-letter FDA Preferred Terms (PTs) as an alternative entry for the Global Medical Device Nomenclature (GMDN) field in the GUDID. Future requirements will only allow 5-digit GMDN Codes. While a specific deadline for replacing FDA PTs has not yet been published, the FDA strongly encourages labelers to adopt GMDN Codes as soon as possible. Early action ensures manufacturers stay ahead of compliance requirements and avoid last-minute updates.
GMDN Obsolete Codes Update Initiative
In a June 2023 notice, the FDA urged labelers to update obsolete GMDN and FDA PT Codes by August 14, 2023. Despite the elapsed deadline, non-compliance remains a significant issue. As of January 15, 2025, over 197,000 GUDID records still contain obsolete GMDN Codes that require updating. Manufacturers addressing the FDA PT Replacement Initiative may simultaneously identify obsolete GMDN Codes in their records, creating an opportunity to resolve both issues at once.
How Reed Tech Can Help
Reed Tech offers specialized professional services to assist manufacturers with these compliance initiatives.
If your devices have been submitted with FDA Preferred Term Codes or obsolete GMDN Codes, Reed Tech is here to help. We can assist you in identifying deprecated/obsolete codes, replacing them with the correct codes, and resubmitting your data. Get in touch with one of our experts for more information on how Reed Tech can make updating your GMDN codes quick and easy.

Questions about health authorities and Unique Device Identification (UDI)? We monitor health authorities around the globe for the latest requirements and exceptions. If you have UDI questions, we can help. Email us: [email protected] or call +1-215-557-3010