FDA Guidance Documents·· 原文未提供具体时分
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff
Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators 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：2017-01-13。官方主题：Premarket, Clinical - Medical, 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