FDA Guidance Documents·· 原文未提供具体时分
Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff
Deciding When to Submit a 510(k) for a Change to an Existing Device: 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：2017-10-25。官方主题：Premarket, 510(k), Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices)。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov