Anna B.

Awaiting reviewAwaiting reviewFiled October 13, 2026139 wordsFDA-2026-N-7874-0196

FDA questions it names

Questions this filing names by number.

Q21 · Clinicians, institutions and societies

Not yet read. 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 22 years of experience working in pediatic ICU, home health, PACU, adult and pediatric med/surge, and school nursing. I am an adaptable lifelong learner, a mom, a sandwich generation caregiver, and an Army wife. I am submitting this comment in response to the request for feedback above.

I have not yet worked directly with generative AI tools in patient care.

Regarding Question 21 (Who is responsible for watching): In my work, I have seen nurses voices should be heard. We know things. We see things. We care deeply. When a nurse raises a concern, please invest time and energy attempting to listen to understand the concern

Thank you for considering these comments.

Sincerely,
Anna Bazil, RN, BSN
School / public health nursing

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