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

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

Feds want feedback on AI-enabled medical device regulation

The federal government issued a discussion paper Tuesday as it seeks feedback on regulating certain artificial intelligence-enabled medical devices.

FDA Seeks Input on Generative AI Medical Device Regulation

The agency released a discussion paper to address the unique risks and potential of generative artificial intelligence in the healthcare ecosystem. The Food and Drug Administration (FDA) Digital Health Center of Excellence released a discussion paper regarding the regulation of generative artificial intelligence (AI)-enabled medical devices. The document is intended to engage stakeholders on the challenges and risks associated with the technolog…