指导原则库

牙科树脂类充填材料产品注册审查指导原则（2025年修订版）（2025年第6号）

种植用口腔骨填充材料注册审查指导原则（2025年第6号）

骨科植入物抗菌性能评价注册审查指导原则（2025年第6号）

全自动化学发光免疫分析仪注册审查指导原则（2025年修订版）（2025年第4号）

乙型肝炎病毒基因分型检测试剂注册审查指导原则（2025年修订版）（2025年第4号）

人MTHFR基因多态性检测试剂注册审查指导原则（2025年第4号）

ALDH2基因多态性检测试剂注册审查指导原则（2025年第4号）

丙型肝炎病毒核糖核酸检测试剂注册审查指导原则（2025年修订版）（2025年第4号）

体外诊断试剂稳定性研究注册审查指导原则（2025年第4号）

雌激素受体、孕激素受体抗体试剂及检测试剂盒注册审查指导原则（2025年修订版）（2025年第4号）

Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff

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

外周药物涂层球囊扩张导管临床试验注册审查指导原则（2025年第2号）

关于公开征求《腹腔内窥镜手术系统注册审查指导原则 第4部分：风险管理（征求意见稿）》意见的通知

Data Standards Catalog

Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs

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

Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators

官方主题：Good Clinical Practice (GCP), Pediatric Product Development

关于第二次公开征求《体外诊断试剂变更注册审查指导原则（征求意见稿）》意见的通知

Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff

官方主题：Premarket,

Developing Drugs for Optical Imaging

官方主题：Clinical - Medical

Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Pediatric Product Development

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket,

Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Postmarket, Premarket, Digital Health

Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products: Draft Guidance for Industry and Other Interested Parties

官方主题：Artificial Intelligence

Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers

官方主题：Administrative / Procedural

Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：IVDs (In Vitro Diagnostic Devices)

Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices

官方主题：Clinical - Medical

Global Unique Device Identification Database (GUDID): Guidance for Industry and Food and Drug Administration Staff

官方主题：GUDID, Labeling, UDI

关于公开征求《有源医疗器械荧光成像性能评估注册审查指导原则（征求意见稿）》等2项医疗器械注册审查指导原则意见的通知

Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration Staff

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

Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Orthopedic

Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Orthopedic

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review: Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations

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

关于公开征求《牙科树脂类充填材料产品注册审查指导原则（2024年修订版）（征求意见稿）》等6项医疗器械注册审查指导原则意见的通知

关于公开征求《人类白细胞抗原（HLA）基因分型检测试剂注册审查指导原则（征求意见稿）》等2项医疗器械注册审查指导原则意见的通知

关于公开征求《整形美容用透明质酸钠类注射填充剂注册审查指导原则（2024年修订版）（征求意见稿）》意见的通知

关于公开征求《电子听诊器注册审查指导原则（征求意见稿）》等58项第二类医疗器械注册审查指导原则意见的通知

关于公开征求《富血小板血浆制备器注册审查指导原则（征求意见稿）》意见的通知

乳房植入体产品注册审查指导原则（2024年修订版）（2024年第28号）

Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Guidance for Industry

官方主题：Clinical - Medical, Pediatric Product Development

Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, 510(k), Dental