FDA Guidance Documents·· 原文未提供具体时分
eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff
eCopy Program for Medical Device Submissions: 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：2025-12-03。官方主题：Premarket, User Fees, Administrative / Procedural, 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