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Domingo Alpajora

CliniciansClinicianFiled October 18, 2026228 wordsFDA-2026-N-7874-0323
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Themes it raises

2 of the 21 themes in the docket, each with the passage we counted, verbatim.
Devices that plan and take actionsFDA Q26
“Easy for AI to hallucinate or missing real world context and all AI work should require clearance from a bedside personal before implementing in patient care.”
Whether human oversight is real oversightFDA Q3, Q4, Q14, Q20, Q21, Q26
“Clearance from someone at the bedside to judge AI output should be mandatory.”

FDA questions it names

Questions this filing names by number.

Q2 · The spectrum of device activityQ4 · Generalist and specialist usersQ14 · Comparators and acceptance criteriaQ26 · Agentic devices

Machine-assisted draft, pending human review. The source text and highlighted passages appear below. Read the filing on regulations.gov ↗

The comment as filed

Comment submitted on regulations.gov. Passages we counted are highlighted.

Re: FDA-2026-N-7874 — Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback

I am an RN, BSN with 11 years of experience working at the bedside in an intensive care unit. I am submitting this comment in response to the request for feedback above.

My comments come from direct experience with AI-suggested orders or care plans.

Regarding Question 2 (When does information become an instruction): In my work, I have seen AI automate Care Plans

Regarding Question 4 (Which clinicians count as users): FDA should require nursing input when validating AI tools that affect how nurses work

Regarding Question 14 (What counts as good enough): In my work, I have seen. FDA should require AI tools to not make decisions on a patients care without validation from a doctor or nurse. Hospitals are desperately looking for AI to completely validate care to save on staffing and think there are certain thing that cannot be 100% validated. Clearance from someone at the bedside to judge AI output should be mandatory.

Regarding Question 26 (AI that acts on its own): FDA should require all clearance from doctors, nurses, respiratory therapists before implementing AI work. Easy for AI to hallucinate or missing real world context and all AI work should require clearance from a bedside personal before implementing in patient care.

Thank you for considering these comments.

Sincerely,
Domingo Alpajora, RN, BSN
Critical care nursing

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