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

Press Release

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Tuesday, July 26, 2022   15:00-17:00
* Given the impact of COVID-19, the conference was held online.

Agenda / List of Handouts

  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

Confidentiality Classification of Handout

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

Reference Document 1

PMDA Science Board Rules

Reference Document 2

PMDA Science Board Subcommittee Rules

Reference Document 3

Rules for Commissioning Members of the Science Board and the Subcommittees

Reference Document 4

Memorandum of Understanding on Disclosure of Minutes and Handouts

Reference Document 5

Memorandum of Understanding for Requesting Attendance of External Experts

Reference Document 6

Memorandum of Understanding on Management of Working Group

 

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