The 1st Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning

Agenda

1. Introduction of the Subcommittee Members
2. About the Science Board
3. Purpose, Work and Schedule for the Subcommittee
   • About Subcommittee on Software as a Medical Device utilizing AI (Professor SAKUMA, Chairperson of the Subcommittee)
4. Lectures on Software as a Medical Device Utilizing AI and Discussion
   • Review of Machine Learning-enabled Medical Devices (Office of Software as a Medical Device)
   • Summary of study on appropriate framework for regulating software as medical devices (SaMD) using innovative technologies including artificial intelligence/machine learning (Dr. NAKAOKA)
5. Others

List of Handouts　

• Document 1     Member List of the Subcommittee
• Document 2     About the Science Board
• Document 3     Lecture Materials by Professor SAKUMA, Chairperson of the Subcommitte
• Document 4     Lecture Materials by Office of Software as a Medical Device
• Document 5     Lecture Materials by Dr. NAKAOKA
• Ref.1                PMDA Science Board Rules
• Ref.2                PMDA Science Board Subcommittee Rules
• Ref.3                Rules for Commissioning Members of the Science Board and the Subcommittees
• Ref.4                Memorandum of Understanding on Disclosure of Minutes and Handouts
• Ref.5                Memorandum of Understanding for Requesting Attendance of External Experts
• Ref.6                Memorandum of Understanding on Management of Working Group