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US FDA issues AI/ML Software as a Medical Device Action Plan

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Based on stakeholder feedback, the Action Plan outlines five actions the US FDA intends to take

The US Food and Drug Administration (FDA) recently issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence.

The release states that the Action Plan is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device” and outlines five actions the US FDA intends to take, which include:

  • Further developing the proposed regulatory framework, including issuing draft guidance on a predetermined change control plan;
  • Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms;
  • Fostering a patient-centered approach, including device transparency to users;
  • Developing methods to evaluate and improve machine learning algorithms; and
  • Advancing real-world performance monitoring pilots.

The US FDA anticipates this action plan will continue to evolve as AI/ML-based SaMD is a rapidly progressing field. The agency welcomed continued feedback in this area and will engage with stakeholders on these efforts. It will also continue to collaborate across the US FDA to build a coordinated approach in areas of common focus related to AI/ML.

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