VIA ELECTRONIC TRANSMISSION
Kyle Diamantas, JD
Acting Commissioner
U.S. Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
RE: Considerations for the Regulation of Generative AI-Enabled Medical Devices: Discussion Paper and Request for Feedback
Dear Acting Commissioner Diamantas,
On behalf of the American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS), representing more than 4,000 neurosurgeons nationwide, we appreciate the opportunity to submit comments on the Food and Drug Administration’s (FDA) Considerations for the Regulation of Generative AI-Enabled (GenAI) Medical Devices discussion paper, published on August 18, 2026.
The discussion paper addresses several issues of significant importance to neurosurgical patients and providers. In particular, the AANS and CNS comment on the assessment of risk, competency-based premarket evaluation, and postmarket monitoring of GenAI devices.
In summary, the AANS and CNS recommend that the FDA:
- Refine its proposed risk framework by evaluating the accuracy, reliability, and potential clinical consequences of GenAI-generated outputs, rather than relying solely on the type of activity the GenAI system performs;
- Move beyond the “non-directive” versus “action-directing” framework and instead assess GenAI systems based on the degree to which their outputs influence clinical decisions, with appropriate safeguards;
- Consider requiring certain safeguards, especially for patient-facing GenAI functions, that are activated when a model’s confidence is low or when the system detects a heightened risk of hallucination;
- Encourage developers to incorporate risk-based safeguards that account for the complexity of the clinical question and the clinical expertise of the user to reduce the risk of misinterpretation;
- Assess GenAI risk based on the overall impact of multi-turn conversations and the foreseeable
- clinical actions they influence, not individual responses viewed in isolation;
- Evaluate GenAI-enabled devices in the context of the clinical decisions they influence and the downstream consequences of referral-related errors;
- Assess transparency as part of Clinical Proficiency, with expectations proportionate to a device’s intended use and risk profile, to ensure users can understand, evaluate, and appropriately rely on GenAI-generated outputs;
- Tailor premarket evidence expectations to the intended use, risk profile, level of autonomy, and potential impact of the technology on clinical decision-making and patient outcomes, ensuring that regulatory requirements are appropriately aligned with risk; and
- Establish clear, risk-based Predetermined Change Control Plan (PCCP) policies that allow appropriately validated lower-risk GenAI updates to proceed without new premarket review while maintaining oversight of higher-risk modifications.
Click here to view the full Comments on FDA Regulation of Generative AI-Enabled Medical Devices (FDA-2026-N-7874)
