FDA Announces a Public Workshop on Unique Device Identification

The FDA’s public workshop, on the proposed Unique Device Identification System is scheduled for February 12, 2009 in Gaithersburg, MD. The purpose of the public workshop is to obtain information to help FDA better understand the issues involved in the establishment of a unique device identification system (UDI system) and request comments on this topic.

President Bush signed into law an amendment to the Food, Drug, and Cosmetic Act requiring the establishment of a UDI system. Specifically the new section 519(f) states, “The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.”

You can find more information about the UDI system at http://www.fda.gov/cdrh/ocd/udi/