title: [Understanding and Thinking on America Clinical Evaluation of Medical Devices].
abstract: This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions.
authors.forename: Fuqiang
authors.initials: F
authors.lastname: Yuan
authors.forename: Peng
authors.initials: P
authors.lastname: Yuan
authors.forename: Gang
authors.initials: G
authors.lastname: Deng
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration