FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML): Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The plan describes a multi-pronged approach to advance the agency’s oversight of AI/ML-based medical software.

The data from AI has great potential to transform healthcare by providing insights and enabling more personalized medicine. FDA wants to ensure that such software is safe and effective and will improve the quality of care that patients receive.

“This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,” says Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH). “The plan outlines a holistic approach based on total product life-cycle 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.”

The plan outlines five actions that FDA intends to take, including:

  • Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time).

  • 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.

  • Advancing real-world performance monitoring pilots.

The plan is a response to stakeholder feedback received from a discussion paper published in April 2019. FDA says it welcomes continued feedback and will continue to build a coordinated approach in areas of common focus related to AI/ML.

AI/ML-based devices have unique considerations that necessitate a proactive patient-centered approach to their development and utilization that takes into account issues including usability, equity, trust, and accountability, says FDA. One way that the agency is addressing these issues is through the promotion of the transparency of these devices to users, and to patients more broadly, about the devices’ functioning. FDA emphasizes the need for manufacturer’s to be transparent about the functioning of AI/ML-based devices to ensure that users understand the benefits, risks, and limitations of these devices.

Sherrie Trigg

Editor and Director of Medical Content

To download a copy of the plan, go here .


Medical Design Briefs Magazine

This article first appeared in the February, 2021 issue of Medical Design Briefs Magazine.

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