HIBCC Accredited By U.S. FDA As UDI Issuing Agency

The U.S. Food and Drug Administration (FDA) recently announced HIBCC’s accreditation as an Issuing Agency for Unique Device Identifiers (UDIs).  

In the final rule released in September of 2013, FDA identified the global HIBC Supplier Labeling Standard (SLS) as an appropriate data format for UDI.  The HIBC SLS has also been recognized by the European Commission in their developing regulation on device identification, as well as by the International Medical Device Regulators Forum (IMDRF).

After today’s announcement, HIBCC President and CEO, Robert A. Hankin, Ph.D. commented, “The UDI initiative is fundamental to enhancing patient safety and cost containment measures. HIBCC is pleased to be serving  as  an  FDA-accredited  Issuing Agency to  assist the  industry  in  efficient  and  comprehensive UDI  implementation.” 

In support of the UDI initiative, HIBCC has developed the UDI Resource Center, which includes numerous implementation documents, the LIC application, and an on‐line ‘UDI Generator’. 

About HIBCC
HIBCC is an industry-sponsored, Standards Development Organization (SDO) founded in 1983 to develop a healthcare-specific standard for the unique identification of medical products. HIBCC is accredited by the American National Standards Institute (ANSI), the European Committee for Standardization (CEN) and is recognized by the International Organization for Standardization (ISO). Our efforts are supported worldwide by affiliate offices in Europe and Asia Pacific. For more information, visit www.hibcc.org.