The US Food and Drug Administration (FDA) has released its first artificial intelligence and machine learning action plan. The action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software.

The Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan is a response to stakeholder feedback from an April 2019 discussion paper.

“This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,” said Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health.

“The plan outlines a holistic approach based on total product lifecycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effective software functionality that improves the quality of care that patients receive. To stay current and address patient safety and improve access to these promising technologies, we anticipate that this action plan will continue to evolve over time.”

As part of the Action Plan, the Agency has five intended actions and goals:

  • Develop an update to the proposed regulatory framework. Including through the issuance of a draft guidance on the Predetermined Change Control Plan.
  • Strengthen FDA’s encouragement of the development of good machine learning practices.
  • Support a patient-centered approach and transparency to users of AI/ML-based devices.
  • Support 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.
  • Advance real-world performance pilots to provide additional clarity on what a real-world evidence generation program could look like.

The agency will also continue to collaborate across the FDA to build a coordinated approach in areas of common focus related to AI/ML.

The full Action Plan can be found on the FDA’s website.

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