FDA Guidance Documents·· 原文未提供具体时分
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Guidance for Industry and Food and Drug Administration Staff
Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: 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：2019-08-30。官方主题：Premarket, Premarket Approval (PMA)。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov