JAMA : the journal of the American Medical Association
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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. ⋯ Strong oversight by the FDA protects the long-term success of industries by focusing on evaluation to advance regulated technologies that improve health. The FDA will continue to play a central role in ensuring safe, effective, and trustworthy AI tools to improve the lives of patients and clinicians alike. However, all involved entities will need to attend to AI with the rigor this transformative technology merits.