US FDA concerns AI/ML Applications as an Action Plan for Medical Devices

The US Food and Drug Administration (FDA) recently released 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 notes that the Action Plan is a direct response to input from stakeholders to the “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device” discussion paper in April 2019 and details five steps that the US FDA plans to take, including five actions.

  • Further implementation of the proposed regulatory structure, including the issuance of draught guidance on a predetermined control plan for change

  • Supporting the development of good practises for machine learning to test and strengthen algorithms for machine learning

  • Promoting a patient-centered approach, including openness of devices to users

  • Developing methods for evaluating and developing algorithms for machine learning

As AI/ML-based SaMD is a rapidly progressing area, the US FDA anticipates this action plan will continue to develop. The Agency has welcomed continued input in this sector and will participate in these activities with stakeholders. Collaboration around the US FDA will also help to develop a structured strategy in areas of common focus related to AI/ML.


a good approach indeed and hope in future our country too launches such schemes to make healthcare more efficient and accessible.

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