FDA's New Action Plan Includes Work with Xavier AI World Consortium

Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan

The U.S. Food and Drug Administration (FDA) 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.

Step 2 of the five-step Action Plan is to encourage harmonization of Good Machine Learning Practice (GMLP) development. According to the plan, “development and adoption of these practices is important not only for guiding the industry and product development, but also for facilitating oversight of these complex products, through manufacturer’s adherence to well established best practices and/or standards. There have been many efforts to date to describe standards and best practices that could comprise.”

Given the need for GMLP, FDA has been an active participant in numerous efforts related to their development, including standardization efforts and collaborative communities, including officially becoming a member of the Xavier AI World Consortium Collaborative Community.

As part of this Action Plan, FDA is committing to deepening its work in these communities in order to encourage consensus outcomes that will be most useful for the development and oversight of AI/ML-based technologies.

To learn more and download the Action Plan, click here.