FDA Guidance Documents·· 原文未提供具体时分
Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff
Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff
AI 导读
FDA 官方历史目录记录；Final guidance；发布日期：2013-10-01。官方主题：Premarket, Good Clinical Practice (GCP), 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