指导原则库

离心式血液成分分离设备技术审查指导原则（2015年第112号）

Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling : Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Investigational Device Exemption (IDE), Premarket Approval (PMA)

关于《丙型肝炎病毒核糖核酸测定试剂注册技术审查指导原则》第一次征求意见的通知

关于《医疗器械软件注册申报资料指导原则》征求意见的通知

关于《医用实验室用电气设备产品技术要求中电气安全部分的编写要求》、《第三类体外诊断试剂产品技术要求附录编写要求》公开征求意见的通知

Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

关于《人乳头瘤病毒（HPV）核酸检测及基因分型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《全自动化学发光免疫分析仪技术审查指导原则》第一次征求意见的通知

关于征求《透明质酸钠类面部注射填充材料临床试验基本要求》意见的通知

关于征求《透明质酸钠类面部注射填充材料非临床注册申报资料基本要求》意见的通知

关于征求对《角膜塑形用硬性透气接触镜上市前临床试验指导原则》（第二次征求意见稿）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》第二次征求意见的通知

关于《乙型肝炎病毒基因分型检测试剂技术审查指导原则》第二次征求意见的通知

关于对《常见骨科创伤产品说明书编写规范》及《创伤产品说明书参考格式》征求意见的通知

大动脉覆膜支架系统的临床试验指导原则（征求意见稿）

Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration Staff

官方主题：Radiological Health

Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff

官方主题：Premarket, 510(k)

Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Molecular Diagnostic Instruments with Combined Functions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

关于《结核分枝杆菌复合群核酸检测试剂注册技术审查指导原则》第一次征求意见的通知

Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket,

关于对《经导管植入式主动脉瓣膜临床试验审查原则》征求意见的通知

Custom Device Exemption: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

关于征求对《骨科常见无源植入类产品说明书编写规范（征求意见稿》及《脊柱产品说明书参考格式（征求意见稿）》意见的通知

Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff

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

Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff

官方主题：Labeling, UDI

FDA Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff

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

关于征求对《角膜塑形用硬性透气接触镜上市前临床试验指导原则》意见的通知

Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff

官方主题：Labeling

In Vitro Companion Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Administrative / Procedural

关于《一次性使用膜式氧合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

Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology: Guidance for Industry

官方主题：Premarket, Food & Color Additives, Records

Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket,

Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

官方主题：Advertising

国家食品药品监督管理总局关于发布植入式心脏电极导线产品注册技术审查指导原则的通告（第10号）

国家食品药品监督管理总局关于发布医疗器械产品技术要求编写指导原则的通告（第9号）

Considerations When Transferring Clinical Investigation Oversight to Another IRB: Guidance for IRBs, Clinical Investigators, and Sponsors

官方主题：Good Clinical Practice (GCP)

国家食品药品监督管理总局关于发布医用控温毯等14个医疗器械产品注册技术审查指导原则的通告（第7号）