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FDAの概要ステータス:人工知能および機械学習(AI/ML)医療機器としてのソフトウェア(GMLP)Summary Status of the FDA: Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device (GMLP)

FDAにおける GMLP策定の動向を2019年から2022年までの概要図としてサマリーしました。
以下の「Newsletter Vol.3 No.8で2021年10月の動きを参照ください」
① On April 2, 2019, the FDA published a discussion paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback” that describes the FDA’s foundation for a potential approach to premarket review for artificial intelligence and machine learning-driven software modifications.
(1) Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper
https://www.fda.gov/media/122535/download
② The FDA have publicly accept comments and questions from each stakeholder regarding the AI-ML issues presented in the discussion paper.
(2) Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Request for Feedback
https://www.regulations.gov/document/FDA-2019-N-1185-0001
https://www.regulations.gov/document/FDA-2019-N-1185-0001/comment
③ The FDA held a Workshop on Medical Devices with AI-ML capabilities in Radiological Imaging on February 25 -26, 2020.
(3) Public Workshop – Evolving Role of Artificial Intelligence in Radiological Imaging
④ On January 12, 2021, the FDA released an action plan that describes its future course of action after reviewing comments and questions from various stakeholders.
(4) FDA Releases Artificial Intelligence/Machine Learning Action Plan
https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device
https://www.fda.gov/news-events/press-announcements/fda-releases-artificial-intelligencemachine-learning-action-plan
https://www.fda.gov/media/145022/download
⑤ Next Acton: Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan
(on page-7)
In summary, as part of this Action Plan, the Agency is highlighting the following intended actions and goals: