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FDA Guidance Documents·· 原文未提供具体时分

Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff

Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff

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FDA 官方历史目录记录;Final guidance;发布日期:2016-09-21。官方主题:Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE)。请通过官方原文与附件查阅文件。

来源:FDA Guidance Documents · fda.gov