Small Regulatory Steps For AI In SaMD

By Sarah Beale

Regulators seem hesitant to come out with regulations about software as a medical device (SaMD) with artificial intelligence/machine learning (AI/ML). The U.S. Food and Drug Administration has an “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” and they’re in the process of gathering feedback from stakeholders.

Recently released guiding principles for good machine learning practice in medical devices and other regulatory documents, are giving medical device companies an indication of what regulations might look like.

In this blog we review how the principles require of data sets as well as what the regulators refer to as “the Human-AI team.”