FDA Guidance Documents·· 原文未提供具体时分
Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors
Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and Sponsors
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FDA 官方历史目录记录；Final guidance；发布日期：2006-01-01。官方主题：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