4 The Science Board https://www.pmda.go.jp/english/rs-sb-std/sb/science-committee/0010.html 5 Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning https://www.pmda.go.jp/english/rs-sb-std/sb/subcommittees/0023.html 6 Report on AI-based Software as a Medical Device (August 28, 2023) : Japanese version (https://www.pmda.go.jp/files/000263891.pdf), English version (https://www.pmda.go.jp/files/000266099.pdf) 10 The PMDA has established the Science Board consisting of external experts with various expertise as an organization to deliberate matters related to scientific aspects of operations for reviews, safety measures, etc. of drugs, medical devices, and regenerative medical products. 4 The Science Board aims to improve the quality of reviews, safety the following topics: 【Background and objective】 As artificial intelligence (AI) technology has advanced, the practical use of Software as a medical device (SaMD), which clarified the issues related to SaMD with such function in developing and implementing it in society as medical device software. *For details of the discussion on this topic, please refer to the link of the Science Board. 5 【Theme】 ⚫ 【Results】 The "Report on AI-based Software as a Medical Device (SaMD)" (August 28, 2023) was prepared and released in both Japanese and English.6 It is expected to design the development process properly and perform scientific and rational performance evaluations based on the points to consider presented in this report. measures, etc. by promoting appropriate evaluations and practical applications. In FY 2023, reports were published on may change the post-marketing performance with machine learning function, is expected. The subcommittee has Trend analysis of activities for establishing medical-device regulations and medical-device safety standards in Japan and overseas ⚫ Various issues including biases in machine learning, reuse of test data in post-marketing learning, clinical information database, etc. Promotion of Scientific Review 3.2 Promotion of scientific approach The Science Board Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
元のページ ../index.html#10