Chris Cataldi

These comments reflect my own views as a registered nurse and do not represent the views of my employer or any organization I am affiliated with.

As a practicing CRNA and founder of a clinical-AI company building agentic systems for anesthesia, I support the paper’s two-axis risk framework and urge CDRH to treat action authority — not output variability — as the decisive axis: what matters most is what the system is permitted to do, not just what it might say. Human gates belong at the action layer, and every agentic action should produce a tamper-evident receipt, so failures are auditable rather than arguable. I support the shift toward continuous postmarket monitoring in the actual environment of use, including monitoring the underlying foundation model for drift — and on Question 18, accepting greater premarket uncertainty is reasonable only if postmarket surveillance is real, continuous, and staffed, not a plan on paper. Finally, the periodic clinician review the paper envisions should draw explicitly on practicing bedside clinicians: the failure modes of AI in clinical care are workflow failures, and the people who know the workflow are the people delivering the care. — Chris Cataldi, CRNA