The FDA regulatory framework for GenAI-enabled medical devices is designed to ensure that advanced AI technologies meet stringent safety and efficacy standards. A team of innovators developing a GenAI-enabled diagnostic tool must navigate the FDA’s comprehensive requirements, starting with the Federal Food, Drug, and Cosmetic Act, which mandates classification and regulation of devices intended for diagnostic and therapeutic purposes. While GenAI models offer remarkable benefits—such as enhanced diagnostic accuracy, predictive analytics, and personalized treatment planning—their adaptability poses regulatory challenges. The FDA’s approach includes premarket evidence, postmarket monitoring, and adaptive risk controls to handle GenAI’s continuous learning and potential for bias. Innovators must work within this framework, detailing device performance, managing model transparency, and conducting ongoing validation. The FDA’s Total Product Lifecycle (TPLC) approach provides a structured pathway, from planning to real-world performance evaluation, ensuring that GenAI-enabled devices align with medical safety standards and remain effective post-deployment, ultimately advancing patient care.
