Procedures for Meetings of the Medical Devices Advisory Committee: Guidance for Industry and Food and Drug Administration Staff
Procedures for Meetings of the Medical Devices Advisory Committee: Guidance for Industry and Food and Drug Administration Staff
FDA 官方历史目录记录;Final guidance;发布日期:2017-09-01。官方主题:Premarket, Advisory Committees, 510(k), Premarket Approval (PMA), HUD/HDE, Administrative / Procedural, Labeling, Safety - Issues, Errors, and Problems, Anesthesiology , Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Physical Medicine, Orthopedic, Ophthalmic, Obstetrical & Gynecological, Neurological, Molecular and Clinical Genetics, Immunology & Microbiology , Cardiovascular , Hematology & Pathology , General Hospital & Personal Use , General & Plastic Surgery , Gastroenterology-Urology , Ear, Nose & Throat , Dental , Clinical Chemistry & Clinical Toxicology , Radiology, Laser Notice。请通过官方原文与附件查阅文件。
来源:FDA Guidance Documents · fda.gov