FDA法规讲座之510(K)文件编写(ppt 56页)

FDA法规讲座之510(K)文件编写目录：
一、510(k)编写技巧
二、医疗器械的变更和特殊510(k)
三、第三方审核项目

 

FDA法规讲座之510(K)文件编写内容提要：
A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval(PMA).
510(k)报告作为FDA上市前通知的技术文本形式，有着相应的完整法规要求
法规21 CRF 807
用词准确、数据可信、信息可靠

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