指导原则库

关于《接受医疗器械境外临床试验数据技术指导原则（征求意见稿）》征求意见的通知

总局关于发布超声骨密度仪等5项注册技术审查指导原则的通告（2017年第180号）

总局关于发布红外线治疗设备等5项注册技术审查指导原则的通告（2017年第177号）

关于《医疗器械临床试验设计指导原则（征求意见稿）》征求意见的通知

Product Labeling for Certain Ultrasonic Surgical Aspirator Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Labeling, Safety - Issues, Errors, and Problems, Obstetrical & Gynecological, General & Plastic Surgery

Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket,

Deciding When to Submit a 510(k) for a Software Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Digital Health

Deciding When to Submit a 510(k) for a Change to an Existing Device: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices)

Administrative Procedures for CLIA Categorization: Guidance for Industry and Food and Drug Administration Staff

官方主题：User Fees, Administrative / Procedural, CLIA (Clinical Laboratory Improvement Amendments)

关于《冠状动脉药物洗脱支架临床前研究技术审查指导原则（征求意见稿）》征求意见的通知

关于《移动医疗器械注册技术审查指导原则》（征求意见稿）公开征求意见的通知

关于《持续葡萄糖监测系统产品技术审查指导原则》（征求意见稿）公开征求意见的通知

关于《眼科飞秒激光治疗机注册技术审查指导原则（征求意见稿）》征求意见的通知

Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff

官方主题：Combination Products

Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs

官方主题：Investigation & Enforcement, Good Clinical Practice (GCP), Pediatric Product Development

关于《人表皮生长因子受体（EGFR）突变基因检测试剂技术审查指导原则》（征求意见稿）公开征求意见的通知

关于《硬性光学内窥镜（有创类）注册技术审查指导原则（征求意见稿）》征求意见的通知

关于《超声软组织切割止血刀注册技术审查指导原则（征求意见稿）》征求意见的通知

关于《眼科超声诊断设备注册技术审查指导原则》征求意见的通知

Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Microbiology, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Premarket Approval (PMA)

骨组织手术设备注册技术审查指导原则（2017年修订版）（2017年第146号）

总局关于发布红外乳腺检查仪等3项注册技术审查指导原则的通告（2017年第146号）

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

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

关于《X射线计算机体层摄影设备注册技术审查指导原则》公开征求意见的申请

Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：510(k), Anesthesiology , Neurological, Cardiovascular , General Hospital & Personal Use , Digital Health, Dental , Radiological Health

Procedures for Meetings of the Medical Devices Advisory Committee: Guidance for Industry and Food and Drug Administration Staff

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

关于《软性接触镜注册技术审查指导原则》征求意见的通知

总局关于发布牙科种植机注册技术审查指导原则的通告（2017年第124号）

牙科种植机注册技术审查指导原则（2017年第124号）

关于《肠道病毒核酸检测试剂注册审查指导原则》（征求意见稿）公开征求意见的通知

关于《口腔颌面曲面体层X射线机注册技术审查指导原则》公开征求意见的通知

关于《结核分枝杆菌特异性细胞免疫反应检测试剂技术审查指导原则》（征求意见稿）公开征求意见的通知

关于《丙型肝炎病毒核酸基因分型检测试剂注册技术审查指导原则》（征求意见稿）公开征求意见的通知

关于《质子/碳离子治疗系统临床评价技术审查指导原则》公开征求意见的通知

关于公开征求子宫内膜去除设备临床评价技术审查指导原则意见的通知

关于《幽门螺杆菌抗原/抗体检测试剂技术审查指导原则》（征求意见稿）公开征求意见的通知

关于《一次性使用输注泵（非电驱动）注册技术审查原则》征求意见的通知

关于《血液及血液成分贮存袋注册技术审查指导原则-非临床评价部分》征求意见的通知

关于《血液浓缩器注册申报技术审查指导原则（征求意见稿）》征求意见的通知

关于公开征求眼科光学相干断层扫描仪注册技术审查指导原则意见的通知