Open for Public Comment: Content of Premarket Submissions for Device Software Functions

Submit comments by 02/02/2022

Content of Premarket Submissions for Device Software Functions Draft Guidance for Industry and Food and Drug Administration Staff

Link here to FDA site and here to download .pdf of document.

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Trainees Speaker Event: Siba el Hussein

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FDA’s virtual public workshop: Transparency of Artificial Intelligence/Machine Learning-enabled Medical Devices