目的：通过对FDA医疗器械指南开发程序的研究，为建立我国医疗器械指南管理提供借鉴。方法：采用指南文件翻译和分析方法，主要资料来源于美国食品药品管理局网站上已发布的医疗器械相关指南及相关法规文件。结果与结论：FDA对医疗器械指南进行分类管理，在21C F R中明确了良好指南管理规范的要求，并有专门的“规范的指南开发程序”。我国应以此为借鉴，制定符合我国国情的医疗器械指南开发程序，完善我国医疗器械指南编写和管理工作，为提升我国医疗器械行业技术要求和管理水平提供保障。%Objective: Based on the research of the FDA guidance development procedures formedical device, in order to provide references for the establishof medical devices guidancedevelopment procedures in China. Methods: By guidance translation and analysis method, guidance documents relevant to device procedures were col ected from FDA website. Results and Conclusions: The FDA conductclassiifed management for guidance, clear the requirements of “good guidance practices” in 21 CFR and have normative guidance development procedures.It should be as a reference in our country, inaccordancewith the situation of our country to formulate guidance development procedures for medical device, al-round development of our country medical device guidance writing and managementwork, provide guarantee to promote industry technical requirements and management level medical device industry.
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