November 6, 2012
In July of this year, FDA proposed rules for a Unique Device Identification (UDI) System. All comments on the proposed rule are due by Nov. 7, 2012. The purpose of the rule is to reduce existing obstacles to identifying specific medical devices and reduce medical errors resulting from misidentification of a device or confusion about its appropriate use. Upon finalizing the rule, FDA plans a staged implementation over the next seven years. Below are three key points about the regulations and the potential benefits of the UDI system.
Thomas. P. Gross, M.D., M.P.H., and Jay Crowley, M.S., “Unique Device Identification in the Service of Public Health,” NEJM 2012; 367: 1583 (Oct. 25, 2012).