中国食品药品监管Issue(3)：18-27,10.DOI:10.3969/j.issn.1673-5390.2024.03.002
医疗器械有效的科学证据及其监管考虑
Valid Scientific Evidence and Regulatory Considerations for Medical Devices
廖茜雯 1姚晨2
作者信息
- 1. 北京大学第一医院 北京大学临床研究所
- 2. 北京大学第一医院 北京大学临床研究所||海南省真实世界数据研究院
- 折叠
摘要
Abstract
Against the backdrop of rapid advancements in medical technology,the reliance on traditional randomized controlled trials(RCTs)for the regulatory approval of medical devices has become increasingly inadequate.The inherent complexity and variability of medical devices often pose methodological and ethical challenges to clinical trials,substantially hindering the applicability and effectiveness of RCTs.This paper advocates for a paradigm shift in medical device regulatory decision-making by embracing a wider variety of valid scientific evidence,including real-world data and real-world evidence,aligning with the adaptive regulatory guidelines of the U.S.Food and Drug Administration.This approach aims to strike a balance between fostering innovation and ensuring the safety and effectiveness of medical devices,proposing a more flexible and inclusive regulatory framework tailored to the unique characteristics of medical devices.关键词
真实世界数据/真实世界证据/随机对照试验/临床证据等级/医疗器械监管决策/创新性监管审批Key words
real-world data/real-world evidence/randomized controlled trials/levels of evidence/medical device regulatory decision-making/innovative regulatory approval分类
医药卫生引用本文复制引用
廖茜雯,姚晨..医疗器械有效的科学证据及其监管考虑[J].中国食品药品监管,2024,(3):18-27,10.
