运用监管科学工具促进创新医疗器械开发
Using Regulatory Science Tools to Facilitate the Development of Innovative Medical Devices
姚立新1
作者信息
摘要
本文探讨了监管科学的定义及其与研究科学的区别,介绍了美国食品药品监督管理局(FDA)用于医疗器械开发的监管科学工具、优先事项及相关计划.面对技术进步与行业发展的挑战,监管机构需要借助监管科学,通过有效的监管科学工具,将有价值的科学工具转换为有价值的监管工具,助力加快安全性、有效性、质量和效用得以保障的医疗器械开发与上市速度,满足患者亟需.
Abstract
This paper explores the definition of regulatory science and how it differs from research science.It introduces regulatory science tools,priorities,and related programs of Food and Drug Administration(FDA)for the development of innovative medical devices.Faced with the challenges of emerging technologies and industry evolution,regulatory agencies need to leverage regulatory science.By utilizing effective regulatory science tools,valuable scientific tools can be transformed into valuable regulatory tools.This approach accelerates the development and marketing authorization of medical devices,ensuring their safety,efficacy,quality,and performance to meet the urgent needs of patients.
关键词
监管科学/定义/监管科学工具/优先事项/创新医疗器械开发Key words
regulatory science/definition/regulatory science tools/priorities/development of innovative medical devices引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据