Research and Enlightenment of FDA’s Digital Health Software Pre-Cert Program

Abstract

Objective To study the supervision experiences of the US digital health software pre-cert program, and to provide reference for the scientific supervision of digital health in China. Methods By reviewing domestic and international databases from PubMed, Web of Science, CNKI, and Wanfang, as well as FDA’s website, the innovative regulatory pathway of software pre-cert was investigated comprehensively. Then, This method was compared with the current regulatory actions in China so as to propose some suggestions for digital health regulation in line with our national conditions. Results and Conclusion FDA’s software pre-cert program emphasizes assessment at the organizational level and product level first, streamlines the pre-market review process, and relies on post-market evidence generated from real-world data and elements of excellence appraisal to strengthen post-market regulation of software as a medical device (SaMD). However, post-marketing data in China are difficult to obtain, so this method cannot be copied totally. Currently, we can explore the elements that must be reviewed for registration of medical device according to enlightenment of the program, reduce the burden on enterprises and regulatory agency. At the same time, the post-marketing regulatory system should be improved gradually, and experience in the whole life cycle management of medical device should be accumulated, which can make preparations for enhancing the ability of regulatory innovation.

Keywords

digital health / software pre-cert / pre-marketing review

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