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FDA's New Guidance Proposes Flexible Use of AI in Medical Devices | Foley & Lardner LLP

On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for. ....

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FDA's Guidance on Artificial Intelligence Devices

FDA expects manufacturers to commit to transparency and real-world performance monitoring, to periodically update FDA on changes implemented as part of the approved pre-specifications and algorithm change protocol and follow Good Machine Learning Practice guiding principles ....

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FDA Releases Guidance On Submissions For Ai/Ml-Enabled Devices - Life Sciences, Biotechnology & Nanotechnology

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendation. ....

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FDA Releases Guidance on Submissions for AI/ML-Enabled Devices | Foley Hoag LLP

On April 3, 2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations. ....

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A systems engineering approach to equitable health care solutions ....

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