U.S. Food and Drug Administration (FDA) — Center for Devices and Radiological Health / Digital Health Center of Excellence

Ways to reach them

OPEN CONSULTATION: Considerations for the Regulation of Generative AI-Enabled Medical Devices · Regulatory docket

https://www.regulations.gov/docket/FDA-2026-N-7874

Verified · 2026-09-22

Open to 'device manufacturers, clinicians, consumers, researchers, the public, and other interested parties'. Covers a two-axis risk framework, competency-assessment-based premarket evaluation, postmarket monitoring, and foundation models / agentic AI. Announced 18 August 2026; comments due 19 October 2026.

VERIFIED via the FDA press announcement, which states the docket number and deadline.

Ask a digital health regulatory policy question · Web form

https://www.fda.gov/medical-devices/digital-health-center-excellence/ask-question-about-digital-health-regulatory-policies

Verified · 2026-09-22

Public questions on digital health regulatory policy.

VERIFIED — linked from the Digital Health Center of Excellence page.

MedWatch adverse event reporting · Complaint route

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

Unverified

Patients and clinicians can report harm from an AI-enabled device.

UNVERIFIED as fetched; standard FDA URL.

Named DHCoE email · Email address

none published

Verification expired · 2026-09-22

This route is retained as reference only. Its verification is missing, more than 180 days old, or the contact window is not currently open; do not rely on it until it is re-checked.

n/a

VERIFIED ABSENCE — the Digital Health Center of Excellence page publishes no email address, only the question form and the FDA general line 1-888-INFO-FDA (1-888-463-6332).

Homepage · Homepage

https://www.fda.gov/medical-devices/digital-health-center-excellence

Unchecked

What it does

Regulates AI/ML-enabled medical devices and Software as a Medical Device. Can require premarket clearance (510(k)), De Novo or PMA approval; mandates Predetermined Change Control Plans for adaptive models; can order recalls, issue warning letters, and impose civil money penalties. Runs a Digital Health Advisory Committee. In Aug 2026 it opened a major consultation on how to regulate GENERATIVE AI-enabled devices, including foundation models and agentic AI systems.

Its powers

compel

Honest assessment

This is one of the best-value open windows in the entire US landscape RIGHT NOW. FDA-2026-N-7874 closes 19 October 2026, explicitly invites the public, and explicitly asks about foundation models and agentic systems — meaning frontier-adjacent arguments are in scope here in a way they are not at the FTC. Docket comments are published, read by the review divisions, and FDA routinely publishes a comment-response analysis. The generic 1-888 line and the question form are for regulatory-status queries and will not carry a policy argument.

Notes