Felipe Avila

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.

I am a critical care nurse, and I am writing because the discussion paper does not mention nursing. Its competency-based framework draws only on physician credentialing, such as licensing exams, residency, and fellowship, yet nurses are often the clinicians who use these tools, question their outputs, and catch their errors at the bedside.

I urge the FDA to include nursing when it benchmarks AI competency. Nursing has its own established methods of competency validation, and where nurses are the end users, AI performance should be assessed against them. For agentic systems, the FDA should also require clear points where a clinician must review the system’s work before it takes an irreversible action. In most clinical workflows, that clinician will be a nurse. Finally, in response to Question 21, post-market monitoring should include a clear channel for nurses to report problems, because we are often the first to notice when a tool’s output drifts or fails. These tools should be built, tested, and monitored with the nurse’s judgment in mind.

Respectfully,
Felipe Avila, BSN, RN