8th Global Gastroenterology and Artificial Intelligence Summit Separating AI Hype from Clinical Reality | September 2026-12

12 - Haugen Regulatory Pathway for AI Devices

Pdf Summary

The presentation explains how the FDA approaches regulation of AI-enabled medical devices and software, with patient safety and access to high-quality, effective devices as the central goal. FDA evaluates both traditional medical devices and AI/ML-enabled devices using the same core questions: intended use, benefits, and risks.<br /><br />A major theme is that not all software is regulated as a medical device. FDA oversight depends on the product’s function and risk level. Examples range from non-device products like electronic patient records and general wellness apps, to software that may qualify for enforcement discretion, to regulated products such as endoscopes, AI-based diagnostic tools, and implanted devices.<br /><br />The talk highlights the 21st Century Cures Act, which excludes certain software functions from the device definition, including administrative support, general wellness, electronic patient records, data transfer/display functions, and some clinical decision support software. For clinical decision support to be excluded, all four statutory criteria must be met, including that the software not analyze medical images or signals and that clinicians can independently review the basis for its recommendations.<br /><br />FDA’s General Wellness Guidance is also discussed, explaining that low-risk products promoting healthy lifestyles are generally not actively reviewed as devices. To help stakeholders navigate these distinctions, FDA offers the Digital Health Policy Navigator, an interactive tool that guides users through questions about intended use and software function to determine whether FDA oversight applies.<br /><br />The presentation concludes that advancing AI in gastroenterology requires strong performance testing, clear demonstration of benefit, and thoughtful risk management. FDA emphasizes that it welcomes engagement and collaboration from developers working on AI-enabled health technologies.

Keywords

FDA regulation

AI-enabled medical devices

medical software oversight

patient safety

21st Century Cures Act

clinical decision support

general wellness guidance

digital health policy navigator

risk management

artificial intelligence in gastroenterology