指导原则库

家用体外诊断医疗器械注册技术审查指导原则（2020年第80号）

血清淀粉样蛋白A检测试剂注册技术审查指导原则（2020年第80号）

泌乳素检测试剂注册技术审查指导原则（2020年第80号）

特定蛋白免疫分析仪注册技术审查指导原则（2020年第80号）

Requesting FDA Feedback on Combination Products : Guidance for Industry and FDA Staff

官方主题：Combination Products, Over-the-Counter Drugs

关于公开征求《可降解镁金属骨科植入物注册技术审查指导原则（征求意见稿）》意见的通知

国家药监局关于发布医疗器械注册人开展产品不良事件风险评价指导原则的通告（2020年第78号）

真实世界数据用于医疗器械临床评价技术指导原则（试行）（2020年第77号）

关于公开征求《使用体外诊断试剂境外临床试验数据的技术指南（征求意见稿）》意见的通知

国家药监局关于发布真实世界数据用于医疗器械临床评价技术指导原则（试行）的通告（2020年第77号）

Certificates of Confidentiality: Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff

官方主题：Research, Good Clinical Practice (GCP)

关于公开征求《实时荧光PCR分析仪注册技术审查指导原则（征求意见稿）》意见的通知

Regulatory Considerations for Microneedling Products: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, General & Plastic Surgery

关于征求《医疗器械中应用的纳米材料安全性和有效性评价框架指导原则（征求意见稿）》意见的通知

关于公开征求《一次性使用非吸收性闭合夹注册技术审查指导原则（征求意见稿）》意见的通知

Testing for Biotin Interference in In Vitro Diagnostic Devices: Guidance for Industry

官方主题：Blood, Blood Products, IVDs (In Vitro Diagnostic Devices)

关于公开征求《血管内导管同品种对比临床评价技术审查指导原则（征求意见稿）》意见的通知

Saline, Silicone Gel, and Alternative Breast Implants: Guidance for Industry and FDA Staff

官方主题：Premarket, General & Plastic Surgery , Labeling

关于公开征求《一次性使用注射笔配套用针注册审查技术指导原则（征求意见稿）》意见的通知

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Clinical Chemistry & Clinical Toxicology , Over-the-Counter Drugs

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, CLIA (Clinical Laboratory Improvement Amendments), IVDs (In Vitro Diagnostic Devices), General Hospital & Personal Use , Clinical Chemistry & Clinical Toxicology

Breast Implants - Certain Labeling Recommendations to Improve Patient Communication: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, General & Plastic Surgery , Labeling

Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

官方主题：Premarket,

The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

官方主题：Premarket,

Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

官方主题：Premarket,

球囊扩张导管注册技术审查指导原则(2020年第62号)

输注产品针刺伤防护装置要求与评价技术审查指导原则(2020年第62号)

3D打印患者匹配下颌骨假体注册审查指导原则(2020年第62号)

生物型股骨柄柄部疲劳性能评价指导原则(2020年第62号)

个性化匹配骨植入物及工具医工交互质控审查指导原则(2020年第62号)

国家药监局关于发布球囊扩张导管等6项指导原则的通告(2020年第62号)

同种异体植入性医疗器械病毒灭活工艺验证指导原则（2020年修订版）(2020年第62号)

Recognition and Withdrawal of Voluntary Consensus Standards: Guidance for Industry and Food and Drug Administration Staff

官方主题：Administrative / Procedural

关于公开征求《医疗器械网络安全技术审查指导原则（第二版）征求意见稿》意见的通知

关于公开征求《超声软组织切割止血系统同品种临床评价技术审查指导原则（征求意见稿）》意见的通知

关于公开征求《隐球菌抗原检测试剂注册技术审查指导原则（征求意见稿）》意见的通知

关于公开征求《轮状病毒抗原检测试剂注册技术审查指导原则（征求意见稿）》意见的通知

关于公开征求《遗传性耳聋相关基因突变检测试剂注册技术审查指导原则（征求意见稿）》意见的通知

Conventional Foley Catheters - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Gastroenterology-Urology

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff

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