On October 19, ASGE submitted comments to the Food and Drug Administration (FDA) regarding the agency’s discussion paper, Considerations for the Regulation of Generative AI-Enabled Medical Devices. The FDA is seeking stakeholder input on a regulatory framework addressing risk assessment, clinical evaluation, ongoing monitoring, and oversight of generative artificial intelligence (GenAI) technologies used in medical devices.
ASGE expressed support for a risk-based regulatory approach that balances innovation with patient safety and clinical effectiveness. Drawing on the experience of gastroenterologists using AI in endoscopy and the work of ASGE’s Artificial Intelligence Institute for Gastroenterology (AIGI), the Society emphasized that regulatory standards must reflect how AI technologies perform in real-world clinical settings.
In its comments, ASGE recommended that the FDA establish clinically meaningful performance benchmarks, require appropriate clinical validation, and implement ongoing monitoring to identify changes in device performance and potential patient safety risks. ASGE also emphasized the importance of evaluating how AI technologies influence physician decision-making and ensuring that manufacturers remain accountable for device safety and effectiveness.
As generative AI applications expand into clinical practice, ASGE urged the FDA to engage medical specialty societies in developing regulatory standards that reflect the complexities of patient care and support the safe and effective integration of emerging technologies.