FDA UDI Web Resources
UPDATE: FDA Accredits HIBCC as Issuing Agency for UDI. Read approval letter HERE.
Access FDA’s UDI web resources, including the final regulation, implementation dates and issuing agency accreditation here.
HIBCC Presentations & Guidelines
UDI Formatter Version 2.4
Access the UDI Formatter Version 2.4 here.
Apply for a Labeler Identification Code (LIC)
The FDA has identified the Health Industry Bar Code Supplier Labeling Standard (HIBC SLS) as a data standard for UDI. The FDA regulation requires a product identifier, as well as a labeler identifier, such as the HIBC Labeler Identification Code (LIC).
HIBC Supplier Labeling Standard (SLS) 2.4
Current HIBC Labelers
Additional Resources & Links
European Union’s Proposed UDI System to Align with FDA Regulation Read More Here →
International Medical Device Task Force (IMDRF) Recognizes HIBC for UDI Read More Here →
Hankin Discusses UDI on PMPNews.com
An identification standards body speaks out on the draft regulation for medical devices.
Read Article →
Unique Identifiers for Medical Devices – An interview with HIBCC President Bob Hankin
We’ve been advocating the UDI system for a number of years. In this 2007 interview, HIBCC President, Bob Hankin discussed FDA’s interest in UDI and industry practices at the time.
Read Article →
Global Medical Device Nomenclature (GMDN) Agency Website
This non-profit company, “GMDN Agency”, acting as the Maintenance Agency Secretariat (MAS), functions as the hub in the running and maintenance of the GMDN, providing services and information for access to the GMDN data through this present Internet site or other means.
Visit Website →
Contact HIBCC Today
If you have any questions or comments about the FDA UDI regulation, please contact us via our contact form or call us at 1-855-HIBC-UDI.