FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine

Importance: Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks. This Special Communication reviews the history of the US Food and Drug Administration's (FDA) regulation of AI; presents potential uses of AI in medical product development, clinical research, and clinical care; and presents concepts that merit consideration as the regulatory system adapts to AI's unique challenges. Observations: The FDA has authorized almost 1000 AI-enabled medical devices and has received hundreds of regulatory submissions for drugs that used AI in their discovery and…