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：Labeling, UDI
官方主题：Premarket, Radiological Health
官方主题：Investigational Device Exemption (IDE), Radiological Health, Radiology, Safety - Issues, Errors, and Problems
官方主题：Premarket, Gastroenterology-Urology , Investigational Device Exemption (IDE)
官方主题：Premarket, 510(k), Administrative / Procedural
官方主题：Premarket, 510(k)
官方主题：Premarket, 510(k)
官方主题：Premarket, 510(k)
官方主题：Premarket, 510(k)
官方主题：Combination Products
官方主题：Recalls, Investigation & Enforcement,
官方主题：Administrative / Procedural
官方主题：Clinical - Medical
官方主题：Combination Products
官方主题：Premarket, Postmarket,
官方主题：Premarket, Good Clinical Practice (GCP)
官方主题：Pharmacology/Toxicology
官方主题：Premarket, Gastroenterology-Urology , Good Clinical Practice (GCP)
官方主题：Premarket, 510(k), Orthopedic
官方主题：Device & Drug Safety, General & Plastic Surgery , Labeling, Device & Drug Safety
官方主题：Premarket,
官方主题：Premarket, Administrative / Procedural
官方主题：Export, Import
官方主题：Premarket, Animal Cell-Based Products
官方主题：Labeling, UDI
官方主题：Chemistry, Manufacturing, and Controls (CMC), Labeling, Pharmaceutical Quality
官方主题：Premarket, Investigational Device Exemption (IDE), Neurological
官方主题：Premarket, 510(k), Cardiovascular , Labeling
官方主题：Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
官方主题：Premarket, 510(k), Premarket Approval (PMA)
官方主题：Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), Obstetrical & Gynecological
官方主题：Postmarket, Premarket, 510(k), Labeling, Safety - Issues, Errors, and Problems, Obstetrical & Gynecological, General & Plastic Surgery
官方主题：Premarket, 510(k), Radiology
官方主题：Premarket, 510(k), Orthopedic
官方主题：Combination Products, Over-the-Counter Drugs
官方主题：Research, Good Clinical Practice (GCP)
官方主题：Premarket, General & Plastic Surgery
官方主题：Blood, Blood Products, IVDs (In Vitro Diagnostic Devices)
官方主题：Premarket, General & Plastic Surgery , Labeling
官方主题：Premarket, 510(k), Clinical Chemistry & Clinical Toxicology , Over-the-Counter Drugs