HIBCC UDI and Labeling Resource Center

HIBCC UDI and Labeling Resource Center

How to Become FDA UDI Compliant

Getting Started: HIBCC’s Guide to UDI Compliance
To view the document click here.

HIBCC UDI Fee Schedule
To view the document click 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 LIC. To obtain an LIC click here.

Download the HIBC Supplier Labeling Standard (SLS) 2.5
The HIBC SLS 2.5 is your guide to creating bar codes and UDIs. To view the standard click here.

Download the Mod 43 Check Character Calculation Guide
The Mod 43 Check Character Calculation Guide specifies how to calculate the check character included in every HIBC auto-ID symbol. To view the guide click here.

Sample HIBCC UDI Labels

HIBCC UDI Compliant Label Examples
To view the sample labels click here.

FDA UDI Web Resources

FDA’s Global Unique Device Identification Database (GUDID): Guidance Document
To view the complete document click here.

FDA Accredits HIBCC as Issuing Agency for UDI
Read the approval letter here.

FDA’s UDI web resources
To view the website click here.

HIBCC Presentations & Guidelines

HIBCC Guideline: Understanding FDA’s UDI Regulation
To view the presentation click here.

HIBC Expiration Date Formats Comply with FDA UDI Requirements
To view the document click here.

Why Industry Leaders choose alphanumeric identifiers
To view the brochure click here.

Information for Dental Labelers

HIBC UDI Implementation for the Dental Industry
HIBCC President, Bob Hankin presents to the Dental Trade Alliance. View the presentation Here →

European Dental Industry Organization Expresses Support for the HIBC UDI Read More Here →

UDI Formatter Version 2.4

Access the UDI Formatter Version 2.4 here.

Current HIBC Labelers

Healthcare Companies Registered for HIBC Labeling To view the complete list click here.

Dental Companies Registered for HIBC Labeling To view the complete list click here.

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 →

Device Management Goes Global Article. To view the complete article click here.

FDA Approves HIBC Supplier Labeling Standard for Drug Product Labeling. To view the final rule click here.

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.