美国FDA医疗器械监管数字化转型的进展分析及eSTAR模板的应用

Analysis of the Progress in Digital Transformation of Medical Device Regulation by the FDA and the Application of the Medical Device Electronic Submission Template and Resource(eSTAR)

目的:深入剖析美国FDA数字化转型背景、组织架构、战略重点,在医疗器械监管方面的具体措施,以及在加强医疗器械上市前审查计划方面的进展,以期对我国信息化引领的医疗器械技术审评的现代化起到一定的启示作用。方法:对FDA近年来在数字化转型方面的战略规划及进展进行概述,重点介绍基于可扩展标记语言(Extensible Markup Language,XML)格式的eSTAR模板,分析所依托的语言优势,提高数据标准化、数据系统兼容性,便于数据读取处理分析,有效提高审评过程的一致性、完整性及效率。受理不仅是对资料完整性的审核,也是对数据格式/数据标准的筛选过程,经筛选纳入FDA内部数据库,以便后期调用及统计分析,将数据转化为监管工具。结果与结论:我国医疗器械技术审评注册申报信息化平台迭代升级和数据库构建,应积极应用先进的电子信息技术和基础设施,进一步优化上市前审查流程并节省时间和资源,促进数据读取处理分析共享,将监管数据转变为监管证据和监管新工具,加速数据驱动型数字化转型,提高服务响应速度,提升服务质量。

Objective:To deeply analyze the US FDA's digital transformation background,organizational structure,strategic focus,specific measures in medical device supervision,and progress in strengthening the medical device premarket review plan,so as to play a certain role in enlightening the modernization of medical device technical review led by information technology in China.Methods:The FDA's strategic planning and progress in digital transformation in recent years were summarized,with a focus on the eSTAR template based on the extensible markup language(XML)format.The data was easy to read,analyze and process,and the consistency,integrity,and efficiency of the review process were effectively improved by analyzing the advantages of the language and enhancing data standardization,system compatibility.Acceptance was not only the verifi cation of data completeness but also the screening process of data format/data standards.Once screened,the data was integrated into the FDA's internal databases for later retrieval and statistical analysis to transform data into regulatory tools.Results and Conclusion:The iterative upgrade and database construction of China's medical device technology review registration and application in formation platform should actively apply advanced electronic information technology and infrastructure to further optimize pre-market review process and save time and resources,promote the sharing of data reading,processing,and analysis,transform regulatory data into regulatory evidence and new regulatory tools,accelerate data-driven digital transformation,enhance service response speed,and improve service quality.