Lifecycle Regulation and Evaluation of Artificial Intelligence and Machine Learning-Based Medical Devices

Between 2017-2018, the FDA cleared fourteen AI and ML-based software products as devices, yet the evidence for safety and effectiveness at market entry remains limited, prompting the need for a lifecycle-based regulatory framework. Manufacturers and the FDA should establish pre-approved “safe harbor” modifications for real-time software adaptation, implement guardrails to monitor cumulative changes, and require heightened transparency standards to address the inherent opacity of AI/ML systems and enable informed decision-making by patients and clinicians.