Year-end perspectives: the introduction of new technologies.
The regulatory process for medical devices works well for products that involve incremental change to conventional technologies. The situation is not so clear when radically new technologies are introduced into clinical practice. This article discusses some of the issues that are involved and proposes some new solutions.
Department of Clinical Engineering, University of Liverpool. dfw.ce@liverpool.ac.uk
David
D
Williams
D020811:Biomedical Technology; D004059:Diffusion of Innovation; D004864:Equipment and Supplies; D006801:Humans; D012042:Registries; D013673:Technology Assessment, Biomedical; D014481:United States