FDA releases plan to advance oversight of medical AI software

The Food and Drug Administration today released for comment its first plan for advancing oversight of medical software based on artificial intelligence and machine learning.

“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,” said Bakul Patel, director of the digital health center at FDA’s Center for Devices and Radiological Health. “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.”