FDA is issuing this draft guidance to further develop a regulatory approach tailored to artificial intelligence/machine learning (AI/ML)-enabled devices to increase patients’ access to safe and effective AI/ML-enabled devices, in order to protect and promote public health. This draft guidance describes a least burdensome approach to support the iterative improvement of machine learning-enabled device software functions (ML-DSF) while continuing to assure their safety and effectiveness, as described in FDA’s 2019 AI/ML Discussion Paper and 2021 AI/ML Action Plan.
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