On August 18, 2026, the U.S. Food and Drug Administration’s (“FDA”) Digital Health Center of Excellence, within the Center for Devices and Radiological Health (“CDRH”), released a discussion paper seeking public comment on how the agency should approach generative artificial intelligence-enabled (“GenAI”) medical devices. FDA emphasized that the paper is intended for discussion purposes... READ MORE
FDA Seeks Input on the Future of GenAI-Enabled Medical Device Oversight
Posted on August 26, 2026 in Health Law News
Published by: Hall Render
