指导原则库

Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff

官方主题：Premarket,

总局关于发布无源植入性医疗器械货架有效期注册申报资料指导原则（2017年修订版）的通告（2017年第75号）

关于《全自动血型分析仪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《抗人球蛋白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《ABO、RhD血型抗原检测卡（柱凝集法）注册技术审查指导原则》（征求意见稿）公开征求意见的通知

影像型超声诊断设备（第二类）注册技术审查指导原则（2017年第60号）

总局关于发布超声多普勒胎儿心率仪等4项注册技术审查指导原则的通告（2017年第60号）

关于《人表皮生长因子受体2基因扩增检测试剂盒（荧光原位杂交法）技术审查指导原则》（征求意见稿）公开征求意见的通知

总局关于发布胎儿染色体非整倍体（T21、T18、T13）检测试剂盒（高通量测序法）注册技术审查指导原则的通告（2017年第52号）

手术电极注册技术审查指导原则（2017年修订版）（2017年第41号）

人工颈椎间盘假体注册技术审查指导原则（2017年第23号）

结核分枝杆菌复合群耐药基因突变检测试剂注册技术审查指导原则（2017年第25号）

人工耳蜗植入系统注册技术审查指导原则（2017年第35号）

注射泵注册技术审查指导原则（2017年修订版）（2017年第41号）

医疗器械优先审批申报资料编写指南（试行）（2017年第28号）

光固化机注册技术审查指导原则（2017年第6号）

体外除颤产品注册技术指导原则（2017年第6号）

口腔颌面锥形束计算机体层摄影设备注册技术审查指导原则（2017年第6号）

Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders

官方主题：Premarket, Emergencies,

Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff

官方主题：Premarket, Clinical - Medical, Investigational Device Exemption (IDE)

Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff

官方主题：Investigation & Enforcement, Compounding, Pharmaceutical Quality, Current Good Manufacturing Practice (CGMP)

人工耳蜗植入系统临床试验指导原则（2017年第3号）

Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Premarket, 510(k), Premarket Approval (PMA), Digital Health, Labeling, Safety - Issues, Errors, and Problems

Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff

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

Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors

官方主题：Administrative / Procedural

Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals"): Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Safety - Issues, Errors, and Problems

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

Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Gastroenterology-Urology

关于《牙科纤维桩注册技术审查指导原则（征求意见稿）》征求意见的通知

Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Adverse Event Reporting System (FAERS), Adverse Event Reporting

关于《治疗呼吸机临床评价技术指导原则》（征求意见稿）征求意见的通知

Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: Guidance for Industry and Food and Drug Administration Staff

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

Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Biostatistics, Adverse Event Reporting System (FAERS), 510(k), Adverse Event Reporting, Labeling, Gastroenterology-Urology

Collection of Race and Ethnicity Data in Clinical Trials: Guidance for Industry and Food and Drug Administration Staff

官方主题：Clinical - Medical, Investigational Device Exemption (IDE)

关于2016年度第二类医疗器械注册技术指导原则（第二批）公开征求意见的通知

关于《胎儿染色体非整倍体（T21、T18、T13）检测试剂盒（高通量测序法）指导原则》（征求意见稿）公开征求意见的通知

关于《中心静脉导管产品注册技术审查指导原则》（征求意见稿）征求意见的通知

关于《医用磁共振成像系统临床评价技术指导原则》征求意见的通知

人红细胞反定型试剂注册技术审查指导原则（2016年第131号）

关于《医疗器械网络安全注册技术指导原则》(征求意见稿)征求意见的通知