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On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled "Using Artificial Intelligence and Machine Learning in the Development...
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the...
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This installation of Ropes & Gray's podcast series Non-binding Guidance focuses on FDA regulatory developments in the area of artificial intelligence ("AI") and machine learning. AI and machine learning represent a rapidly growing frontier in digital health, with applications ranging from medical device software used for diagnostic and triaging applications to drug candidate selection to clinical trial design and interpretation. In this episode, FDA regulatory attorneys Kellie Combs, Greg Levine, and Sarah Blankstein explore the development and uptake of these technologies in response to the ...
To embed, copy and paste the code into your website or blog: On January 12, 2021, the U.S. Food and Drug Administration (FDA) released the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan (Action Plan). The Action Plan expresses that the “FDA’s vision is that, with appropriately tailored total product lifecycle-based regulatory oversight, AI/ML-based Software as a Medical Device (SaMD) will deliver safe and effective software functionality that improves the quality of care that patients receive.” The FDA currently regulates and has a...