FDA Review of Radiologic AI Algorithms: Process and Challenges

A Food and Drug Administration (FDA)–cleared artificial intelligence (AI) algorithm misdiagnosed a finding as an intracranial hemorrhage in a patient, who was finally diagnosed with an ischemic stroke. This scenario highlights a notable failure mode of AI tools, emphasizing the importance of human-machine interaction. In this report, the authors summarize the review processes by the FDA for software as a medical device and the unique regulatory designs for radiologic AI/machine learning algorithms to ensure their safety in clinical practice. Then the challenges in maximizing the efficacy of these tools posed by their clinical implementation are discussed. © RSNA, 2024