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)
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 verification 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.
technical review of medical devicesdatabase constructiondigital transformationmodernization
NETL
NSTL
万方数据
