AI, including genAI, presents opportunities to improve patient outcomes, advance public health and accelerate medical innovation. At the same time, these technologies introduce concerns regarding safety and effectiveness across the total product life cycle. Considerations include assessing these devices for their performance, safety and reliability after deployment in real-world settings.
The Food and Drug Administration is requesting public comment to get feedback on current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real world.
The FDA said its request does not represent draft or final guidance. It is not intended to propose or implement policy changes regarding the evaluation of devices that integrate artificial intelligence, including generative AI-enabled technology.It is instead meant to seek early feedback from groups and individuals to advance a broader discussion among the AI healthcare ecosystem on this topic.