指导原则库

国家食品药品监督管理总局关于发布乙型肝炎病毒脱氧核糖核酸定量检测试剂注册技术审查等4项指导原则的通告（第3号）

The Open Public Hearing at FDA Advisory Committee Meetings: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff

官方主题：Advisory Committees, Food & Color Additives

关于《人工耳蜗植入系统临床试验指导原则》（征求意见稿）征求意见的通知

关于《植入式心脏电极导线注册申报指导原则》（征求意见稿）征求意见的通知

Assay Migration Studies for In Vitro Diagnostic Devices: Guidance for Industry and FDA Staff

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

关于《药物滥用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

Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

官方主题：Good Clinical Practice (GCP)

Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA Staff

官方主题：Combination Products

Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff

官方主题：Premarket, Laboratory Tests

关于征集过敏原特异性IgE检测试剂生产企业信息的通知

关于征集肿瘤突变基因（个体化用药指导）检测试剂生产企业信息的通知

关于征集药物滥用检测试剂生产企业信息的通知

Investigational Device Exemption (IDE) Guidance for Retinal Prostheses: Guidance for Industry and FDA Staff

官方主题：Investigational Device Exemption (IDE), Ophthalmic

Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Pediatric Product Development

Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

CPG Sec. 390.225 Early Defects or Noncompliance - 21 CFR 1004.6

官方主题：Investigation & Enforcement,

Financial Disclosure by Clinical Investigators: Guidance for Clinical Investigators, Industry,and FDA Staff

官方主题：Good Clinical Practice (GCP), Investigational Device Exemption (IDE)

Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling

官方主题：Clinical - Medical, Clinical - Pharmacology

Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA: Draft Guidance for Industry and FDA Staff

官方主题：Combination Products

关于《心脏射频消融导管注册技术审查指导原则》征求意见的通知

关于《医用磁共振成像系统注册申报资料指导原则》征求意见的通知

酶联免疫法检测试剂注册技术审查指导原则（2013年第3号）

发光免疫类检测试剂注册技术审查指导原则（2013年第3号）

生物芯片类检测试剂注册技术审查指导原则（2013年第3号）

核酸扩增法检测试剂注册技术审查指导原则（2013年第3号）

国家食品药品监督管理局办公室关于印发酶联免疫法检测试剂注册技术审查等6项指导原则的通知

金标类检测试剂注册技术审查指导原则（2013年第3号）

关于《疝修补补片产品注册技术审查指导原则》第一次征求意见的通知

关于第一次征求《硬性角膜接触镜说明书编写指导原则》及第三次征求《软性亲水接触镜说明书编写指导原则》意见的通知

The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Premarket Approval (PMA), Investigational Device Exemption (IDE)

Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 1003.11

官方主题：Investigation & Enforcement,

关于《一次性使用避光输液器注册技术审查指导原则》征求意见的通知

关于征求《牙科树脂类充填材料注册技术审查指导原则（征求意见稿）》意见的通知

关于《人类免疫缺陷病毒（HIV）检测试剂临床研究注册申报指导原则》（征求意见稿）等三个指导原则第二次征求意见的通知

国家食品药品监督管理局器械司关于征求《医疗器械临床试验质量管理规范（征求意见稿）》意见的通知

关于发布凝血分析仪等12个医疗器械产品注册技术审查指导原则的通知

关于《人类免疫缺陷病毒（HIV）检测试剂临床研究》（征求意见稿）等三个指导原则征求意见的通知

关于《人类免疫缺陷病毒（HIV1+2）检测试剂临床研究注册申报技术指导原则》（征求意见稿）等三个指导原则征求意见的通知

关于第二次征求《软性接触镜说明书撰写指导原则》意见的通知