美国 FDA 第三方机构审核 510(k)及启示 刘清峰* 5 10 (上海医疗器械高等专科学校管理系,上海市 200093) 摘要: 为了解美国 FDA 授权第三方审核机构的进展,采用资料分析法介绍了医疗器械在美 国合法上市的途径及 510(k)申请,分析了第三方审核机构创建的背景,介绍了成为 FDA 授 权第三方审核机构应具备的资格,对第三方机构审核与 FDA 审核做了对比,结论表明第三方 审核制度在审核范围、审批成效及对第三方审核机构的指导管理方面都形成了较为稳定的模 式。建议国内医疗器械企业可以充分利用第三方审核方式走向美国市场,中国医疗器械监督 管理部门的一部分审批职能可由第三方承担,国内符合第三方审评条件的组织应积极争取 FDA 认证授权。 关键词:卫生事业管理;第三方审核;510(k)申请;建议 中图分类号:R19 15 The Thirdparty Review for 510(k) of FDA and Enlightenment 20 25 30 35 40 LIU Qingfeng (Shanghai Medical Instrumentation College Management Department,200093,China) Abstract: In order to learn the progress of the third-party review authorized by FDA, this paper introduced the pathway and 510 (k) application in the United States using the data analysis method, analyzed the creating background of the third party review agency, intruduced the the qualifications of the third party review to be an agency authorized by FDA. It also made a comparisson research between the FDA rewiew and the third-party review. The conclusion showed that the third-party review had formed a relatively stable pattern in the scope, effectiveness and management. It suggested that the domestic medical panies could take advantage of the third-party review mothed to arrive the . market, parts of the approving review functions in China could mited to a third party, those anizations which comply with the c
