FDA Issues Artificial Intelligence/Machine Learning Action Plan | McDermott Will & Emery
To embed, copy and paste the code into your website or blog: On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that FDA intends to take to further its oversight of AI/ML-based SaMD: Further develop the proposed regulatory framework, including through draft guidance on a predetermined change control plan for “learning” ML algorithms FDA intends to publish the draft guidance on the predetermined change control plan in 2021 in...