PHOENIX, AZ (September 20, 2013) – The U.S. Food and Drug Administration (FDA) today released its final regulation on Unique Device Identification (UDI) for medical-surgical products. In the ruling, FDA identifies the Health Industry Bar Code (HIBC) as an acceptable data standard for UDI.

Commenting on the FDA’s final ruling, HIBCC President and CEO, Robert A Hankin, Ph.D. noted, “The FDA’s UDI initiative is fundamental to enhancing patient safety and cost containment measures. HIBCC looks forward to becoming an acting Issuing Agency to assist in providing the tools to implement UDI.”

In support of the UDI initiative, HIBCC has developed the UDI Resource Center, available at It includes numerous implementation documents, as well as an on-line UDI Generator Utility. This web-based tool, now in beta testing, will provide users an easy formatter to quickly enter the required data fields and create the resulting HIBC-UDI.

For additional information on FDA’s UDI initiative and HIBCC’s UDI Resource Center, or to register for a HIBC LIC, contact the HIBCC office at 602.381.1091 or visit

HIBC identified as a data standard for UDI
By: HMT Mag
The Source for Healthcare Information Systems Solutions