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FDA Issues Draft Guidance Related to Marketing Submissions for AI/ML-Enabled DSFs, and Final Guidance Describing the FDA's Adoption of Section 524B "Ensuring Cybersecurity of Devices" | Wilson Sonsini Goodrich & Rosati

Published: April 13, 2023

The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released...

Source: jdsupra.com

AI Machine Learning in Medical Devices FDA Draft Guidance

Published: April 7, 2023

FDA published groundbreaking draft guidance concerning use of artificial intelligence machine learning in medical devices. FDA attempt to provide support for the development of safe and effective medical devices that use machine learning enabled device software functions

Source: natlawreview.com

FDA Issues Draft Predetermined Change Control Plan for Machine-Learning-Enabled Device Software Functions | McDermott Will & Emery

Published: April 7, 2023

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial...

Source: jdsupra.com