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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」

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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

https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/public-workshop-evolving-role-artificial-intelligence-radiological-imaging-02252020-02262020


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:

• Develop an update to the proposed regulatory framework presented in the AI/ML-based SaMD discussion paper, including through the issuance of a Draft Guidance on the Predetermined Change Control Plan.

• Strengthen FDA’s encouragement of the harmonized development of Good Machine Learning Practice (GMLP) through additional FDA participation in collaborative communities and consensus standards development efforts.

• Support a patient-centered approach by continuing to host discussions on the role of transparency to users of AI/ML-based devices. Building upon the October 2020 Patient Engagement Advisory Committee (PEAC) Meeting focused on patient trust in AI/ML technologies, hold a public workshop on medical device labeling to support transparency to users of AI/ML-based devices.

• Support regulatory science efforts on the development of methodology for the evaluation and improvement of machine learning algorithms, including for the identification and elimination of bias, and on the robustness and resilience of these algorithms to withstand changing clinical inputs and conditions.

• Advance real-world performance pilots in coordination with stakeholders and other FDA programs, to provide additional clarity on what a real-world evidence generation program could look like for AI/ML-based SaMD.