指导原则库

关于《眼科超声乳化和眼前节玻璃体切除设备及附件技术审评指导原则（征求意见稿）》征求意见的通知

关于《体外除颤产品注册技术指导原则》征求意见的通知

关于《腔镜用吻合器产品注册技术审查指导原则》（征求意见稿）征求意见的通知

Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff

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

关于对《无源植入性医疗器械临床试验审批审查指导原则》征求意见的通知

Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Radiological Health, Radiology

关于《袜型医用压力带注册技术审查指导原则》（征求意见稿）征求意见的通知

关于《植入式人工耳蜗系统技术审评指导原则（征求意见稿）》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指导原则》意见的通知

关于《含银敷料注册技术审查指导原则》（征求意见稿）征求意见的通知

关于《聚氨酯泡沫敷料注册申报资料指导原则（征求意见稿）》征求意见的通知

Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Clinical - Medical, Good Clinical Practice (GCP), Labeling, General & Plastic Surgery

关于对《人工颈椎间盘假体系统注册技术审查指导原则》征求意见的通知

关于征求《钙磷/硅类骨填充材料注册技术审查指导原则（征求意见稿）》意见的通知

关于征求《光固化机指导原则（征求意见稿）》意见的通知

关于征求《牙科种植机指导原则（征求意见稿）》意见的通知

关于征求《口腔颌面部锥形束计算机体层摄影设备指导原则（征求意见稿）》意见的通知

Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff

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

关于《结核分枝杆菌复合群耐药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

Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Premarket Approval (PMA), Laboratory Tests, IVDs (In Vitro Diagnostic Devices)

关于征集“人表皮生长因子受体（EGFR） 突变基因检测试剂”生产企业信息的通知

Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees: Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff

官方主题：Advisory Committees,

关于《一次性使用血液透析管路注册申报技术审查指导原则（征求意见稿）》征求意见的通知

关于《腹腔内置疝修补补片动物实验技术审查指导原则》第二次征求意见的通知

Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration Staff

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

关于《人类体外辅助生殖技术用液注册技术审查指导原则》（征求意见稿）第一次征求意见的通知

关于对《髋关节假体系统注册技术审查指导原则》征求意见的通知

牙科基托聚合物材料注册技术审查指导原则（2016年第70号）

Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices : Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Labeling, Laboratory Tests, IVDs (In Vitro Diagnostic Devices)

Radiation Biodosimetry Medical Countermeasure Devices: Guidance for Industry and Food and Drug Administration Staff

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

植入式心脏起搏器注册技术审查指导原则（2016年修订版）（2016年第21号）

医用X射线诊断设备（第三类）注册技术审查指导原则（2016年修订版）（2016年第21号）

脉搏血氧仪设备临床评价技术指导原则（2016年第21号）

关于征求对《人工晶状体上市前临床试验指导原则》（征求意见稿）意见的通知

Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), Anesthesiology , Physical Medicine, Orthopedic, Ophthalmic, Obstetrical & Gynecological, Neurological, Cardiovascular , General Hospital & Personal Use , General & Plastic Surgery , Gastroenterology-Urology , Ear, Nose & Throat , Dental , Radiology, Labeling, Safety - Issues, Errors, and Problems

Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE), HUD/HDE, General & Plastic Surgery , Good Clinical Practice (GCP), Labeling

Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k)

国家食品药品监督管理总局关于发布高频手术设备等6个医疗器械注册技术审查指导原则的通告（2016年第21号）

Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration Staff

国家食品药品监督管理总局关于发布一次性使用膜式氧合器和α-氰基丙烯酸酯类医用粘合剂注册技术审查指导原则的通告（2016年第6号）