FDA Sees Unique Challenges In Governing Gen AI-Enabled Medical Devices

Generative artificial intelligence-enabled medical devices are posing unique regulatory challenges for FDA, agency officials said at the inaugural meeting of FDA’s digital health advisory committee last week, coming as agencies try to fill the legislative void while Congress struggles to pass a comprehensive AI federal regulatory standard. A key regulator said they are uncertain whether FDA will develop new regulations, frameworks and/or guidance to ensure generative artificial intelligence-enabled medical devices are safe and effective. FDA has not yet authorized any...