FDA Guidance Documents·· 原文未提供具体时分
Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards
Investigational IVDs Used in Clinical Investigations of Therapeutic Products: Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards
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FDA 官方历史目录记录；Draft guidance；发布日期：2017-12-18。官方主题：Good Clinical Practice (GCP), Labeling, Investigational Device Exemption (IDE), Investigational New Drug Application (INDA), Laboratory Tests, IVDs (In Vitro Diagnostic Devices)。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov