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