Devices

AI/ML Medical Device Action Plan

David McFarland

— 1 min read
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The CDRH Digital Health Center of Excellence has issued its “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan.” An agency statement (contains a link to the action plan) says the plan is a direct response to stakeholder feedback to a 4/2019 discussion paper on a proposed regulatory framework for modifications to AI/ML software as a medical device. The plan outlines five actions FDA will take: 

  •          further develop the proposed regulatory framework by issuing a draft guidance on a predetermined change control plan;
  •          support the development of good machine learning practices to evaluate and improve machine learning algorithms;
  •          foster a patient-centered approach, including device transparency to users;
  •          develop methods to evaluate and improve machine learning algorithms; and
  •          advance real-world performance monitoring pilots.

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