Agency Seeks Public Input on Measuring and Evaluating Real-World Performance of AI-Enabled Medical Devices; Comments Due December 1

Agency Seeks Public Input on Measuring and Evaluating Real-World Performance of AI-Enabled Medical Devices; Comments Due December 1

The Food and Drug Administration (FDA) issued a Request for Public Comment (RFC) to gather input on how AI-enabled medical devices perform in clinical settings after deployment. The agency notes that the RFC is for discussion purposes only and is not intended to set policy or guidance, but rather seeks early feedback from the public to inform future FDA discussions… (Colocho, October 7, 2025) #Artificial Intelligence, #Health Information Technology, #Medical Devices, #Transparency