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FDA Announces Action Plan for Oversight of AI/ML in Medical Devices

January 28, 2021

Last month, the US Food and Drug Administration released the Artificial Intelligence/Machine Learning-Based Software as a Medical Device (SaMD) Action Plan, the next step in its regulation of intelligent health and healthcare products. The program, which includes heavyweights like Apple and Fitbit/Google among others, has yet to move deep into true learning applications, rightly being wary of freeing the black box to do what it wants with people's health. This Action Plan largely accords with the advice covered in our last newsletter issue for medical image AI. Of particular interest is the FDA's desire to engage with partners in research "to develop methods capable of improving ML algorithms, including ways to eliminate bias and increase generalizability to ensure the algorithm is well-suited for a racially and ethnically diverse patient population", a response to the challenges of obtaining and sharing data for these populations for training of ML models.

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