CMDE 与 FDA 医疗器械及 CDRH 相关指导文件的历史目录。保留原始标题、发布日期和版本状态，点击官方原文或附件阅读全文。历史收录不计入当日新增；正式文件标签表示发布时的状态，现行版本以官方原文为准。
691 条目录记录 · 官方公开目录核对 2026/10/23 · 批量发布通告可能包含多份文件
官方主题：Premarket, Biotechnology, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, Orthopedic, Tissue
官方主题：Investigational Device Exemption (IDE)
官方主题：Premarket, 510(k), Pediatric Product Development, Radiology
官方主题：Labeling, UDI
官方主题：Premarket, 510(k), Labeling, Safety - Issues, Errors, and Problems, Obstetrical & Gynecological, General & Plastic Surgery
官方主题：Postmarket,
官方主题：Premarket, 510(k), Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Digital Health
官方主题：Premarket, 510(k), Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices)
官方主题：User Fees, Administrative / Procedural, CLIA (Clinical Laboratory Improvement Amendments)
官方主题：Combination Products
官方主题：Investigation & Enforcement, Good Clinical Practice (GCP), Pediatric Product Development
官方主题：Premarket, Microbiology, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Premarket Approval (PMA)
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
官方主题：510(k), Anesthesiology , Neurological, Cardiovascular , General Hospital & Personal Use , Digital Health, Dental , Radiological Health
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
官方主题：Premarket,
官方主题：Premarket, Emergencies,
官方主题：Premarket, Clinical - Medical, Investigational Device Exemption (IDE)
官方主题：Investigation & Enforcement, Compounding, Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP)
官方主题：Postmarket, Premarket, 510(k), Premarket Approval (PMA), Digital Health, Labeling, Safety - Issues, Errors, and Problems
官方主题：Postmarket, Recalls, Adverse Event Reporting System (FAERS), 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, Adverse Event Reporting, Combination Products, Safety - Issues, Errors, and Problems, Laser Notice
官方主题：Administrative / Procedural
官方主题：Postmarket, Safety - Issues, Errors, and Problems
官方主题：Premarket, Gastroenterology-Urology
官方主题：Postmarket, Adverse Event Reporting System (FAERS), Adverse Event Reporting
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
官方主题：Postmarket, Biostatistics, Adverse Event Reporting System (FAERS), 510(k), Adverse Event Reporting, Labeling, Gastroenterology-Urology
官方主题：Clinical - Medical, Investigational Device Exemption (IDE)
官方主题：Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE)
官方主题：Premarket, 510(k), Radiological Health, Radiology
官方主题：Premarket, 510(k), Clinical - Medical, Good Clinical Practice (GCP), Labeling, General & Plastic Surgery
官方主题：Premarket, Good Clinical Practice (GCP), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE
官方主题：Premarket, 510(k), Premarket Approval (PMA), Laboratory Tests, IVDs (In Vitro Diagnostic Devices)
官方主题：Advisory Committees,
官方主题：Premarket, Good Clinical Practice (GCP), Pediatric Product Development, Premarket Approval (PMA), HUD/HDE
官方主题：Premarket, 510(k), Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices)
官方主题：Premarket, Emergencies, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Radiological Health
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
官方主题：Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, General & Plastic Surgery , Good Clinical Practice (GCP), Labeling
官方主题：Premarket, 510(k)