ASE Submits Comments on FDA’s GenAI-Enabled Medical Device Discussion Paper

On October 16, ASE submitted comments to the FDA’s Digital Health Center of Excellence on its discussion paper on the regulation of generative AI-enabled medical devices. The letter supports a risk-proportionate regulatory framework and offers detailed, cardiovascular-imaging-specific recommendations across ten areas, including clear boundaries between regulated and non-regulated functions, risk assessment tied to actual clinical workflow, validation of complete devices using cardiology-relevant benchmarks, protection of image integrity and quantitative reliability, risk-matched clinical confirmation standards, representative patient data for generalizability, independent expert involvement, feasible postmarket monitoring, controlled update and change management processes, and explicit safeguards for any device that acts autonomously in clinical care.

This letter reflects ASE’s effort to shape AI regulation before generative tools become embedded in echocardiography workflows, building on ASE’s 2023 AI Policy Statement and its consistent position elsewhere that AI tools in cardiovascular imaging are assistive or augmentative, not a substitute for physician work. By pushing FDA to require specialty-specific validation, protect physicians’ and sonographers’ ability to review and correct AI outputs, and keep monitoring obligations practical for community echo labs and hospitals, ASE aims to ensure that as GenAI tools enter cardiac imaging, they strengthen rather than compromise diagnostic accuracy and patient safety.