FDA Guidance Documents·· 原文未提供具体时分
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : 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：2023-09-08。官方主题：Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, Safety - Issues, Errors, and Problems。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov