Medical Device Legal News with Sam Bernstein: Episode 11
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a...more