Sharonda Davis

CliniciansClinicianFiled October 7, 2026114 wordsFDA-2026-N-7874-0170

FDA questions it names

Questions this filing names by number.

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, MSN with 20 years of experience working at the bedside on a progressive care unit. I am submitting this comment in response to the request for feedback above.

My comments come from direct experience with these AI tools: ambient AI scribes; early-warning alerts such as sepsis alerts; patient chatbots or AI-drafted portal replies; AI triage tools.

Regarding Question 17 (AI that listens, sees, or records): In my work, yes, there are several times that the AI written something confusing or that doesn’t make sense.

Thank you for considering these comments.

Sincerely,
Sharonda Davis, RN, MSN
Progressive care nursing

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