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Entries by Eliza Lawless

10 04 '23

New U.S. FDA Draft Guidance Outlines Path To Faster Modification of AI/ML-Enabled Devices

April 10, 2023/in AI, Cybersecurity, FDA, Health Privacy, Policy/by Eliza Lawless

The U.S. Food and Drug Administration (FDA or Agency) has issued new draft guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device […]