指导原则库

关于2019年度第二类医疗器械注册技术审查指导原则公开征求意见的通知

国家药监局关于发布无源植入性骨、关节及口腔硬组织个性化增材制造医疗器械注册技术审查指导原则的通告(2019年第70号)

无源植入性骨、关节及口腔硬组织个性化增材制造医疗器械注册技术审查指导原则（2019年第70号）

关于公开征求《角膜塑形用硬性透气接触镜说明书编写指导原则（2019年修订版）（征求意见稿）》意见的通知

关于公开征求《乙型肝炎病毒e抗原、e抗体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《硬脑（脊）膜补片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《牙种植体基台产品注册技术审查指导原则（征求意见稿）》意见的通知

Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidance for Industry

官方主题：Administrative / Procedural

Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Cardiovascular , Neurological

Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations: Guidance for Industry and Food and Drug Administration Staff

官方主题：510(k), Premarket Approval (PMA), Labeling, Neurological, Cardiovascular

关于公开征求《整形用面部假体技术审查指导原则（征求意见稿）》意见的通知

关于公开征求《牙科玻璃离子水门汀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《定制式个性化骨植入物等效性模型注册资料技术审查指导原则（征求意见稿）》意见的通知

关于公开征求《体外经皮起搏产品注册技术指导原则》意见的通知

关于公开征求《体外同步复律产品注册技术指导原则》意见的通知

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Premarket, Digital Health

Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration

官方主题：Premarket, 510(k)

关于公开征求《一次性使用乳腺定位丝注册技术审查指导原则（征求意见稿）》意见的通知

The Special 510(k) Program: Guidance for Industry and Food and Drug Administration Staff

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

The Abbreviated 510(k) Program: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

关于公开征求《肌腱韧带固定系统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《3D打印人工椎体注册审查指导原则（征求意见稿）》意见的通知

关于公开征求《定量检测试剂性能评估注册技术审查指导原则（征求意见稿）》意见的通知

Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Good Clinical Practice (GCP), HUD/HDE, Premarket Approval (PMA)

Humanitarian Use Device (HUD) Designations : Guidance for Industry and Food and Drug Administration Staff

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

子宫内膜射频消融设备注册技术审查指导原则（2019年第59号）

关于公开征求《3D打印髋臼杯产品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子宫内膜射频消融设备注册技术审查指导原则的通告（2019年第59号）

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Premarket Approval (PMA), HUD/HDE

关于公开征求《全膝关节假体系统产品注册技术审查指导原则（征求意见稿）》意见的通知

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Premarket Approval (PMA)

关于公开征求《3D打印患者匹配下颌骨假体注册审查指导原则（征求意见稿）》意见的通知

关于公开征求《骨科金属植入物有限元分析资料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《生物可吸收冠状动脉药物洗脱支架动物实验指导原则（征求意见稿）》意见的通知

关于公开征求《个性化匹配骨植入物及配套工具医工交互质控审查指导原则（征求意见稿）》意见的通知

关于公开征求《EB病毒核酸检测试剂技术审查指导原则（征求意见稿）》意见的通知

关于公开征求《疝修补补片临床试验指导原则（征求意见稿）》意见的通知

Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

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

Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff

官方主题：Combination Products

Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff

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