Drug Master Files, manufacturer listings, and Electronic Common Technical Document (eCTD) submissions are foundational to regulatory compliance. Yet even experienced regulatory, quality, and operations...
The global Unique Device Identification (UDI) landscape is entering a critical enforcement phase — and 2026 will be a challenging year for medical device manufacturers operating in the European Union...
The FDA’s final rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements,” establishes a uniform 12-digit format for FDA-assigned National Drug Codes (NDCs) ...
UDI product data is now due for specific scenarios (enforced as of December 8, 2022). Class I and Unclassified medical devices that are required to be labeled with a UDI code must submit product data...
LexisNexis Life Sciences Solutions and ONIX expand strategic alliance to guide pharma customers to market faster Professionals in the life sciences industry rely on unique regulatory affairs expertise...
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 Life Sciences can support manufacturers in achieving compliance.
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.
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.
LexisNexis Life Sciences 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, LexisNexis Life Sciences is here to help. We can assist you in identifying deprecated/obsolete codes, replacing them with the correct codes, and resubmitting your data.
Have questions about health authorities and Unique Device Identification (UDI)? LexisNexis Life Sciences monitors health authorities around the globe for the latest requirements and exceptions.
Contact us