UDI report: FDA needs to educate firms on program
This article was originally published in The Silver Sheet
Executive Summary
FDA needs to explain more clearly to device companies why they need to submit certain information to support a unique device identifier system, a recent UDI pilot test found. FDA contracted with consulting firm GHX to conduct and assess FDA's six-week UDI prototype pilot. Six device firms - including Becton Dickinson (BD), Covidien and GE Healthcare - and five user institutions participated in the pilot. The manufacturers entered data on hundreds of devices. Based on feedback collected by GHX, the consulting firm advised the agency to develop clearer explanations and scenarios about why each piece of information requested from firms to support UDI is necessary to meet FDA requirements and address patient safety issues