摘要
目的了解美国政府关于医疗器械标准的管理体系以及标准制定情况。方法查阅美国食品、药品监督管理局发布的有关文件、法规、相关网站,综合整理分析,了解美国医疗器械标准的概况。结果美国FDA医疗器械管理标准体系是由强制要求与自愿性共识标准结合构成。简要介绍了美国FDA医疗器械监管法规、管理要求、强制性标准以及共识标准。结论美国有关医疗器械标准的管理模式及很多标准可供我国参考。
Objective To study the USA government＇s administrative system about medical device standards as well as the standard making. Methods The relevant documents, regulations, website that USA Food and Drug Administration announced were extensively reviewed, knowing the USA medical device standards synthetically. Results The USA standards system of medical device included regulatory requirements and voluntary consensus standards, This article simply introduced the laws, regulations, performance standards and consensus standards. Conclusion The USA＇s administrative system about medical device standards as well as many standards can be referenced.
出处
《中国修复重建外科杂志》
CAS
CSCD
北大核心
2007年第11期1263-1267,共5页
Chinese Journal of Reparative and Reconstructive Surgery
