FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

FDA seeks feedback on generative AI regulations

The agency published a discussion paper this week as it considers the “unique risks” and potential promise of generative AI for patient care.

FDA considering doctor-like assessment for AI-enabled devices

FDA wants feedback on how to regulate generative AI in medicine

“Generative AI-enabled medical devices are poised to reshape the health technology landscape, and the FDA has an important responsibility to provide thoughtful leadership for this new era,” says radiologist Rick Abramson, MD.

FDA wants public input before regulating AI-enabled medical tools

The Food and Drug Administration is mulling over the future of generative artificial intelligence-enabled medical devices.

FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

Discussion Paper Supports FDA’s Innovation and Global Leadership Strategic Pillar; Public Docket Opens on

FDA seeks feedback on potential regulatory approaches for generative AI-enabled medical devices

The Food and Drug Administration is seeking public feedback on a discussion paper released today on potential regulatory approaches for generative artificial intelligence-enabled medical devices. The paper includes considerations for risk assessment, premarket evaluation, post-market monitoring and other areas. The agency intends to gather early stakeholder input and advance broader discussion on policy frameworks for generative AI. The FDA said…