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

在医疗技术迅速发展的背景下,依靠传统随机对照试验(randomized controlled trial,RCT)进行医疗器械监管的方式逐渐难以满足实际工作需要。医疗器械固有的复杂性和可变性等特征使得其临床试验往往面临着方法学和伦理学上的挑战,极大限制了RCT的适用性和有效性。本文倡导对医疗器械监管决策的范式转变,采用更广泛的有效科学证据类型,包括真实世界数据和真实世界证据,并建议与美国食品药品监督管理局的相关适应性指导原则保持一致。该方法旨在寻求促进医疗器械创新与确保其安全性和有效性之间的平衡,提出一个更为灵活和包容的监管框架,以期更好地适应医疗器械的独特性。

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.