美国医疗器械临床评价详解与思考

Understanding and Thinking on America Clinical Evaluation of Medical Devices

该文介绍了美国医疗器械的风险分类、上市途径,并根据这些内容引出了各种情况下美国FDA对临床评价的要求。同时介绍了医疗器械产品如何开展上市前和上市后的临床评价工作,并通过比较研究我国临床评价与美国临床评价的异同,提出了一些建议。

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.