指导原则库

影像型超声诊断设备（第三类）注册审查指导原则（2023年修订版）（2024年第29号）

Dental Ceramics - 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

Dental Cements - 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

Air Powered Dental Handpieces and Air Motors - 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

关于公开征求《一次性使用麻醉用针注册审查指导原则（征求意见稿）》意见的通知

Dental Impression Materials - 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

椎间融合器注册审查指导原则（2024年修订版）（2024年第24号）

牙胶尖注册审查指导原则（2024年第24号）

牙科种植体（系统）注册审查指导原则（2024年修订版）（2024年第24号）

金属缆线缆索系统注册审查指导原则（2024年第24号）

X射线计算机体层摄影设备能谱成像技术注册审查指导原则（2024年第26号）

脊柱后路内固定系统注册审查指导原则（2024年修订版）（2024年第24号）

椎板固定板系统注册审查指导原则（2024年第24号）

Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff

官方主题：Export, Import, Labeling, Radiology

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Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program : Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff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The Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

官方主题：Premarket,

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Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff

官方主题：Premarket,

关于公开征求《颅内取栓支架注册审查指导原则（征求意见稿）》意见的通知

Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Chemistry, Manufacturing, and Controls (CMC)

Conducting Clinical Trials With Decentralized Elements

官方主题：Clinical - Medical

Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff

官方主题：Investigation & Enforcement, Administrative / Procedural, Radiological Health, Radiology

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff

Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff

FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Administrative / Procedural, Labeling

Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff

官方主题：Premarket, Electronic Submissions,

Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff

官方主题：Premarket,

Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff

一次性使用膜式氧合器（CPB用）注册审查指导原则（2024年修订版）（2024年第23号）

α-氰基丙烯酸酯类医用粘合剂注册审查指导原则(2024年修订版）（2024年第23号）

应用纳米材料的医疗器械安全性和有效性评价指导原则第三部分生物相容性毒理学评价（2024年第23号）

透析液过滤器注册审查指导原则（2024年第23号）

可吸收止血产品注册审查指导原则（2024年修订版）（2024年第23号）

腹腔、盆腔外科手术用可吸收防粘连产品注册审查指导原则（2024年修订版）（2024年第23号）

一次性使用血液透析管路注册审查指导原则（2024年修订版）（2024年第23号）

水凝胶敷料注册审查指导原则（2024年第23号）

一次性使用脑积水分流器注册审查指导原则（2024年修订版）（2024年第23号）

一次性使用无菌侧孔钝针注册审查指导原则（2024年第23号）

一次性使用静脉留置针注册审查指导原则（2024年第23号）

可吸收性外科缝线注册审查指导原则（2024年修订版）（2024年第23号）

Application User Fees for Combination Products: Guidance for Industry and FDA Staff

官方主题：User Fees, Combination Products, Pediatric Product Development