Along with the advancement of artificial intelligence (AI) technology, there is great promise for the implementation of medical devices which change in performance by post-marketing use with machine learning (ML).
The subcommittee reviews the trends of domestic and international regulations and safety standardization activities for AI-based Software as a Medical Device (SaMD), and discusses bias in ML, reuse of test data in post-marketing learning, construction of training data using physical model simulation, and development of medical information databases, etc., as a part of the scope, including analysis of medical imaging, electrocardiograms, and other physiological data.
Member List of the Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
Date | No. | PressRelease | Agenda/List of Handouts | Minutes |
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June 19, 2023 | 6th mtg. | PressRelease | Agenda/List of Handouts | Minutes |
April 4, 2023 | 5th mtg. | PressRelease | Agenda/List of Handouts | Minutes |
February 20, 2023 | 4th mtg. | PressRelease | Agenda/List of Handouts | Minutes |
December 5, 2022 | 3rd mtg. | PressRelease | Agenda/List of Handouts | Minutes |
September 26, 2022 | 2nd mtg. | PressRelease | Agenda/List of Handouts | Minutes |
July 26, 2022 | 1st mtg. | PressRelease | Agenda/List of Handouts | Minutes |