指导原则库

国家食品药品监督管理总局关于发布心脏射频消融导管产品注册技术审查指导原则的通告（第5号）

国家食品药品监督管理总局关于发布牙科树脂类充填材料等5个医疗器械产品注册技术审查指导原则的通告（第6号）

关于《乙型肝炎病毒基因分型检测试剂技术审查指导原则》第一次征求意见的通知

关于《雌激素受体、孕激素受体抗体试剂及检测试剂盒技术审查指导原则》第一次征求意见的通知

Providing Information about Pediatric Uses of Medical Devices: Guidance for Industry and FDA Staff

官方主题：Premarket, Pediatric Product Development

关于征求对《全降解冠状动脉药物洗脱支架动物试验审评原则》和《全降解冠状动脉药物洗脱支架临床试验审评原则》意见的通知

Types of Communication During the Review of Medical Device Submissions: Guidance for Industry and FDA Staff

官方主题：Premarket,

The Meaning of "Spouse" and "Family" in FDA's Regulations after the Supreme Court's Ruling in United States v. Windsor: Questions and Answers: Guidance for Industry, Consumers, and FDA Staff

官方主题：Administrative / Procedural, Food & Color Additives

植入式心脏电极导线产品注册技术审查指导原则（2014年第10号）

心脏射频消融导管产品注册技术审查指导原则（2014年第5号）

Medical Device Tracking : Guidance for Industry and FDA Staff

Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff

官方主题：Premarket, Pediatric Product Development

关于《过敏原IgE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

国家食品药品监督管理总局关于发布医用磁共振成像系统等4个医疗器械产品注册技术审查指导原则的通告（第2号）

Public Availability of Advisory Committee Members' Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff

官方主题：Advisory Committees, Food & Color Additives

关于征集体外诊断试剂及仪器指导原则相关产品生产企业信息的通知

Questions and Answers about eMDR - Electronic Medical Device Reporting - Guidance for Industry, User Facilities and FDA Staff

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

关于征求对《关于重新注册时医疗器械软件申报资料的基本要求》意见的通知

关于征求对《腹（盆）腔外科手术用可吸收防粘连产品注册申报资料指导原则（征求意见稿）》意见的通知

关于《一次性使用血液分离器具产品注册技术审查指导原则》征求意见的通知

关于征求《金属接骨板内固定系统产品注册技术审查指导原则（征求意见稿）》意见的通知

Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff

官方主题：Premarket, Good Clinical Practice (GCP), Investigational Device Exemption (IDE), Laboratory Tests, IVDs (In Vitro Diagnostic Devices)

关于《血液透析浓缩物注册技术审查指导原则》（征求意见稿）征求意见的通知

关于《弓形虫、风疹病毒、巨细胞病毒、单纯疱疹病毒抗体及IgG抗体亲合力检测试剂技术审查指导原则》第二次征求意见的通知

关于《肿瘤个体化治疗相关基因突变检测试剂技术审查指导原则》（第二次征求意见稿）公开征求意见的通知

关于《药物滥用检测试剂技术审查指导原则》（第二次征求意见稿）公开征求意见的通知

Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff

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

国家食品药品监督管理总局关于发布红外线治疗设备等17个医疗器械产品注册技术审查指导原则的通告（第8号）

一次性使用配药用注射器产品注册技术审查指导原则（2013年第8号）

Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff

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

Electronic Source Data in Clinical Investigations: Guidance for Industry

官方主题：Administrative / Procedural, Good Clinical Practice (GCP)

关于《可吸收止血产品注册技术审查指导原则》(征求意见稿)征求意见的通知

IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed: Guidance for IRBs, Clinical Investigators, and Sponsors

官方主题：Administrative / Procedural, Good Clinical Practice (GCP)

Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff

官方主题：Premarket, Digital Health

Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring: Guidance for Industry

官方主题：Investigation & Enforcement, Administrative / Procedural, Good Clinical Practice (GCP)

Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality: Guidance for Industry

官方主题：Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality

关于《弓形虫、风疹病毒、巨细胞病毒、单纯疱疹病毒2型抗体及IgG抗体亲合力检测试剂注册申报资料技术指导原则》（征求意见稿）公开征求意见的通知

关于《肿瘤个体化用药相关基因突变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

Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products: Guidance for Industry and FDA Staff

官方主题：Administrative / Procedural, Combination Products

Rheumatoid Arthritis: Developing Drug Products for Treatment

官方主题：Clinical - Medical