FDA Guidance Documents·· 原文未提供具体时分
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: 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：2016-12-27。官方主题：Postmarket, Recalls, Adverse Event Reporting System (FAERS), 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, Adverse Event Reporting, Combination Products, Safety - Issues, Errors, and Problems, Laser Notice。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov