Nancy Stade

Nancy Stade

Foley Hoag LLP

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FDA Releases Guidance on Submissions for AI/ML-Enabled Devices

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2023, the Food and Drug Administration (FDA) published in the Federal Register an announcement of availability for the draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan...more

4/5/2023  /  Artificial Intelligence , Food and Drug Administration (FDA) , Machine Learning , Manufacturers , Medical Devices , Medical Software , New Guidance , Policies and Procedures , Technology
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