National Nurse Practitioner Entrepreneur Network (Lynn Rapsilber)

See attached file

NNPEN Comment Letter: FDA GenAI-Enabled Medical Devices
Discussion Paper
National Nurse Practitioner Entrepreneur Network (NNPEN) www.nnpen.org

October 11, 2026

Dockets Management Staff (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

Submitted electronically via www.regulations.gov

Re: Docket No. FDA-2026-N-7874 — Considerations for the Regulation of Generative AI-Enabled
Medical Devices: Discussion Paper and Request for Feedback (August 2026)

To the Center for Devices and Radiological Health:

The National Nurse Practitioner Entrepreneur Network (NNPEN) appreciates the opportunity to
comment on CDRH's discussion paper. NNPEN supports nurse practitioners (NPs) who own and operate
independent practices across the United States. Our members are small businesses and frontline
clinicians, many serving rural and underserved communities.

NNPEN supports a risk-based, least burdensome approach to generative AI (GenAI)-enabled devices. We
write with one central message: the framework must reflect who actually delivers care. The discussion
paper repeatedly uses physicians as the reference user and performance standard. NPs are licensed,
board-certified clinicians who diagnose, treat, and prescribe, and in many states practice with full
authority. A framework that omits them will misjudge real-world risk and real-world benefit.

We offer six recommendations, keyed to the paper's discussion questions.

1. Use provider-neutral language and include NPs as users, adjudicators, and
comparators (Questions 4 and 14)
Questions 4 and 14 ask about "generalist and specialist physicians" as device users and as the
performance standard. Elsewhere the paper uses "healthcare professional" and "clinician." NNPEN urges
CDRH to:

• Replace "physician" with "clinician" or "healthcare professional" throughout any future
guidance.
• State expressly that NPs qualify as expert adjudicators and members of clinician comparator
panels (Sections V.B, V.C, and V.D.1).
• Require that benchmarking and clinical confirmation reflect the clinicians who will actually use
the device, including NPs in primary care, psychiatric-mental health, and specialty practice.

A device validated only against physician users and physician workflows has not been validated for a
large share of the settings where it will be deployed.
2. Do not treat generalist access to specialty knowledge as presumptively higher risk
(Question 4)
The paper recognizes that a function helping a generalist approach a specialist question "may
meaningfully extend access to specialty knowledge" (Section IV). For NP-owned practices in shortage
areas, that access is often the difference between timely care and a months-long referral wait. Risk
should turn on the device's function, the consequence of error, and its safeguards, not on the credential
of the user. NNPEN also supports assessing performance against what would occur without the device,
such as delayed specialist review or no care at all (Question 15).

3. Keep accountability with manufacturers and protect small practices from unfunded
monitoring duties (Question 21)
Section VI.B names clinicians and healthcare institutions as having potential postmarket roles.
Independent practices lack the compliance, informatics, and legal staff of health systems. NNPEN
recommends that:

• Manufacturers remain solely accountable for postmarket monitoring and performance.
• Any practice-level role be voluntary, limited to simple adverse event and error reporting through
a manufacturer-provided channel, and free of new documentation burdens.
• Monitoring obligations be scaled so they do not become a barrier to adoption by small practices.

4. Require transparency to end users, not only to FDA (Questions 24 and 25)
The proposed Foundation Model Master Files would be held confidentially by FDA (Section VII.A).
Practice owners who deploy these tools would see none of that information. NNPEN recommends that
manufacturers be expected to give deploying clinicians:

• Advance, plain-language notice of changes to the underlying model or device behavior.
• A clear statement of intended use, known limitations, and populations in which performance
was not tested.
• Summary results of periodic re-benchmarking.

Clinicians cannot supervise a tool whose behavior changes without their knowledge.

5. Weigh over-escalation as a real harm (Question 6)
NNPEN agrees that both directions of error matter. Tools that systematically direct patients to
emergency care create cost, anxiety, and unnecessary testing, and they bypass the primary care
relationship. Evaluation of triage functions should include whether the device appropriately directs
patients to available primary care and urgent care options, including their established NP.

6. Preserve affordability and competition (Questions 16 and 18)
Third-party certification, sequestered benchmarks, and clinical confirmation add cost that is passed to
purchasers. NNPEN asks CDRH to scale evidence to risk, keep third-party participation voluntary or feelimited, and avoid program designs that favor the largest vendors and health systems. Small practices
should not be priced out of safe, beneficial tools.
Conclusion
NNPEN supports CDRH's goal of timely patient access to safe and effective GenAI-enabled devices. That
goal is best met by a framework that names NPs as clinicians, keeps accountability with manufacturers,
and gives small practices the transparency they need to use these tools responsibly. We welcome the
opportunity to serve as a resource and to participate in future stakeholder engagement.

Respectfully submitted,

Lynn Rapsilber, DNP, APRN, ANP-BC, FAANP Co-Founder and Chief Executive Officer National Nurse
Practitioner Entrepreneur Network (NNPEN) www.nnpen.org

References
1. U.S. Food and Drug Administration, Center for Devices and Radiological Health. Considerations
for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for
Feedback. August 2026. Docket No. FDA-2026-N-7874.
2. U.S. Food and Drug Administration. Executive Summary for the Digital Health Advisory
Committee Meeting: Total Product Lifecycle Considerations for Generative AI-Enabled Devices.
November 2024.
3. U.S. Food and Drug Administration. Artificial Intelligence-Enabled Medical Devices List.

Disclaimer: AI (Claude) was used in the creation of this document. The information contained was
reviewed, verified, and vetted by Lynn Rapsilber, DNP, APRN, ANP-BC, FAANP, CEO of The National Nurse
Practitioner Network