Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff

FDA 官方历史目录记录；Final guidance；发布日期：2017-09-12。官方主题：Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, Clinical - Medical, Good Clinical Practice (GCP), Labeling, Pediatric Product Development, 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, Radiological Health。请通过官方原文与附件查阅文件。