Accredited Issuing Agencies for UDI

As of September 2014, there are three issuing agencies for UDI that have been accredited by the FDA. Issuing agencies operate a system for assignment of UDIs.

The U.S. FDA UDI Final Rule indicates that not all product types need to have the same issuing agency, so medical device companies can use more than one.

Not all issuing agencies are accredited in other countries, so it’s important to review where each issuing agency is recognized if your products are sold globally.

Each issuing agency operates differently, so make sure you understand how your company would implement the standards for each agency.

FDA Accredited Issuing Agencies:

GS1
Date of Initial Accreditation: December 17, 2013
Initial Accreditation Granted through: December 17, 2016

Health Industry Business Communications Council (HIBCC)
Date of Initial Accreditation: December 26, 2013
Initial Accreditation Granted through: December 26, 2016

ICCBBA
Date of Initial Accreditation: February 12, 2014
Initial Accreditation Granted through: February 12, 2017


USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.