美国FDA 审批流程概述 美国食品和药物管理局 (FDA) 是一个联邦机构,负责保护公众健康,确保各种产品的安全性、有效性和保障,包括人类和兽药、医疗器械、疫苗、生物制剂、食品、化妆品和烟草制品。 FDA 成立于 1906 年,在维护公众健康和促进制药和医疗保健行业创新方面发挥着至关重要的作用。 历史背景 FDA 的...
• Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy, and Considerations 还包括如下回顾性审查指南: Retrospective Review List of Guidances for 1982, 1992, 2002, and 2012 1982 Final Guidances None 1992 Final Guidances Review Criteria for Premarket Approval of In Vitro...
（1）FDA与NMPA均将医疗器械划分为Ⅰ、Ⅱ、Ⅲ三类，其中FDA主要是根据其潜在风险程度进行分级，而NMPA除...
③、医疗器械3类⼀般进⾏上市前批准,即Premarket Approval (PMA),需要提交审核费⽤ 3、审核通过后使⽤FDA官⽹的FURLS⽹络系统注册制造商信息: ①、注册年费:每年10⽉1日⾄12⽉31日之间⽀付官⽅年费(场地注册 Establishment Registration) ②、列出注册的医疗器械(Medical Device Listing) 4. 医疗...
Medical Device Recalls: Get It Right the First Time: Comment on “Medical Device Recalls and the FDA Approval Process” Rita F. Redberg, MD, MSc; Sanket S. Dhruva, MD Archives of Internal Medicine Editor's Correspondence FDA Recalls Not as Alarming as They Seem Jason T. Connor, PhD; ...
814 医疗器械的上市前批准 PREMARKET APPROVAL OF MEDICAL DEVICES 820 质量体系规章 QUALITY SYSTEM REGULATION 821 医疗器械跟踪要求 MEDICAL DEVICE TRACKING REQUIREMENTS 822 上市后监视 POSTMARKET SURVEILLANCE 860 医疗器械分类程序 MEDICAL DEVICE CLASSIFICATION PROCEDURES 861 性能标准制定程序 PROCEDURES FOR PERFORMANCE...
SUBCHAPTER H - MEDICAL DEVICES PART 874 EAR, NOSE, AND THROAT DEVICESSubpart A - General Provisions § 874.1 - Scope. § 874.3 - Effective dates of requirement for premarket approval. § 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (th...
SUBCHAPTER H - MEDICAL DEVICES PART 880 GENERAL HOSPITAL AND PERSONAL USE DEVICES Subpart A - General Provisions § 880.1- Scope. § 880.3- Effective dates of requirement for premarket approval. § 880.9- Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Ac...
https://www.fda.gov/medical-devices/device-registration-and-listing/access-electronic-registration https://www.access.fda.gov/oaa/logonFlow.htm?execution=e1s1 (对于以上四点,也可以参看FDA 网页介绍 How to Register and List) (https://www.fda.gov/medical-devices/device-registration-and-listing/how...
Studies Involving Investigational Devices FDA’s inspection of clinical investigators conducting foreign trials includes device trials in support of a premarket approval application (PMA) or a premarket notification (510(k)) submission. For device studies conducted outside the U.S., FDA will accept ...