Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices: Guidance for Industry and Food and Drug Administration Staff

FDA 官方历史目录记录；Final guidance；发布日期：2016-03-22。官方主题：Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), Anesthesiology , Physical Medicine, Orthopedic, Ophthalmic, Obstetrical & Gynecological, Neurological, Cardiovascular , General Hospital & Personal Use , General & Plastic Surgery , Gastroenterology-Urology , Ear, Nose & Throat , Dental , Radiology, Labeling, Safety - Issues, Errors, and Problems。请通过官方原文与附件查阅文件。