The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025. The draft guidance provides insights on how FDA plans to apply total product life cycle (TPLC) principles that have historically applied to traditional hardware medical devices to artificial intelligence (AI)-enabled software device functions. Read more in our alert.
FDA issues Artificial Intelligence-Enabled Device Software Functions draft guidance
