FDA Guidance Documents·· 原文未提供具体时分
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration Staff
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry 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：2018-09-25。官方主题：510(k)。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov