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Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: Guidance for Industry and Food and Drug Administration Staff
Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: 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：2016-11-07。官方主题：Premarket, Advisory Committees, 510(k), Premarket Approval (PMA), HUD/HDE, Clinical - Medical, Good Clinical Practice (GCP), Labeling, Safety - Issues, Errors, and Problems, Laser Notice, Neurological。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov