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, CLIA (Clinical Laboratory Improvement Amendments), IVDs (In Vitro Diagnostic Devices), General Hospital & Personal Use , Clinical Chemistry & Clinical Toxicology
官方主题：Premarket, General & Plastic Surgery , Labeling
官方主题：Premarket,
官方主题：Premarket,
官方主题：Premarket,
官方主题：Administrative / Procedural
官方主题：Premarket, 510(k), Gastroenterology-Urology
官方主题：Investigation & Enforcement, Good Clinical Practice (GCP)
官方主题：Premarket, 510(k), Neurological
官方主题：Investigation & Enforcement,
官方主题：Investigation & Enforcement,
官方主题：Postmarket, Premarket, Combination Products, Digital Health
官方主题：Cellular & Gene Therapy, Tissue
官方主题：Electronic Submissions,
官方主题：Premarket, 510(k), Investigational Device Exemption (IDE), Gastroenterology-Urology , Good Clinical Practice (GCP)
官方主题：Administrative / Procedural
官方主题：Safety - Issues, Errors, and Problems
官方主题：Orthopedic, Premarket Approval (PMA)
官方主题：Postmarket,
官方主题：Combination Products
官方主题：Premarket, Labeling
官方主题：510(k), Premarket Approval (PMA), Administrative / Procedural
官方主题：Investigation & Enforcement,
官方主题：Device & Drug Safety
官方主题：Premarket, 510(k), Clinical - Medical, Good Clinical Practice (GCP), Labeling, General & Plastic Surgery
官方主题：Premarket, 510(k), Orthopedic
官方主题：Recalls,
官方主题：CLIA (Clinical Laboratory Improvement Amendments)
官方主题：Premarket, Postmarket, CLIA (Clinical Laboratory Improvement Amendments), 510(k)
官方主题：Premarket,
官方主题：Combination Products
官方主题：Premarket, Administrative / Procedural, Device & Drug Safety, Premarket Approval (PMA)
官方主题：Premarket, Administrative / Procedural, Device & Drug Safety, HUD/HDE, Premarket Approval (PMA)
官方主题：Premarket, Administrative / Procedural, Device & Drug Safety, Premarket Approval (PMA)
官方主题：Premarket, Administrative / Procedural, Premarket Approval (PMA)
官方主题：Administrative / Procedural
官方主题：Premarket, 510(k), Cardiovascular , Neurological
官方主题：510(k), Premarket Approval (PMA), Labeling, Neurological, Cardiovascular
官方主题：Postmarket, Premarket, Digital Health
官方主题：Premarket, 510(k)