Medical Device Legal News with Sam Bernstein: Episode 11
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more