IDEAL-D: a rational framework for evaluating and regulating the use of medical devices

著者: Art Sedrakyan, Bruce Campbell, José G. Merino, Richard E. Kuntz, Allison Hirst, Peter McCulloch - BMJ 2016 被引用: 201

High profile device failures have highlighted the inadequacies of current regulation. Art Sedrakyan and colleagues call for a move to a graduated model of approval and suggest a framework to achieve this goal