HIBCC Submission to FDA on the requirement for a Unique Device Identifer (UDI)

3 January 2007

The Food and Drug Administration (FDA) late in 2006 called on submissions from Stakeholders on the implementation of a UDI for medical devices, with the objective of obtaining information on how the use of a UDI may reduce medical errors, facilitate device recalls and improve medical device adverse event reporting.

During the comment period, the FDA intended to learn about the feasibility, utility, benefits and costs associated with developing and implementing a UDI system for medical devices. In addition, the agency intended to hear about various automatic identification technologies, such as bar code and RFID, which could be used with a UDI system.

HIBCC responded to this request, and drafted a submission addressing the issues within its purview. HIBCC was also represented in a public meeting held by the FDA on the 25th October 2006.

The essence of the HIBCC submission is to support the implementation of a UDI for medical devices, so long as the UDI is based on existing international standards.

To download the HIBCC submission to the FDA, please click here.

For additional information contact:
Kirk Kikirekov
(02) 9797 0883