Advarra (Lauri Carlile)

Thank you for the opportunity to comment. Please see the attached response from Advarra, Incorporated.

Date: October 19, 2026
To: Dockets Management Staff, Food and Drug Administration
Subject: Docket No. FDA-2026-N-7874 “Comments on Considerations for the Regulation of Generative AIEnabled Medical Devices: Discussion Paper and Request for Feedback”
Submitted electronically via www.regulations.gov

Advarra, Incorporated (Advarra) is a U.S.-based company that provides institutional review board (IRB) and
institutional biosafety committee (IBC) research review and oversight services, compliance and quality
assurance services, inspection readiness and auditing, and technology platforms in support of clinical
research operations.
Advarra appreciates the opportunity to comment on the Food and Drug Administration’s (FDA’s) August
2026 discussion paper and feedback request, “Comments on Considerations for the Regulation of Generative
AI-Enabled Medical Devices: Discussion Paper and Request for Feedback” (Docket No. FDA-2026-N-7874).
Advarra supports FDA’s consideration of flexible, risk-proportionate methods for clinically confirming
generative AI (GenAI)-enabled medical devices. The range of clinical confirmation approaches described in
the discussion paper could help sponsors generate meaningful evidence without requiring a prospective
clinical study in every case.
For this framework to operate effectively, sponsors, investigators, and IRBs will need additional direction on
how these approaches interact with 21 CFR Parts 50, 56, and 812. They will also need decision-useful
information about the configured device, its supporting evidence, potential failure modes, human oversight,
and changes made during an active investigation.
Advarra recognizes FDA’s statement that the applicability of Parts 50, 56, and 812 is outside the scope of the
current discussion paper. We respectfully recommend that FDA maintain the paper’s current focus while
establishing a coordinated follow-on workstream to address these issues through guidance, meaningful
examples, and/or stakeholder engagement.
In closing, Advarra is grateful for the opportunity to provide FDA with our comments on this discussion
paper. Please feel free to contact us, as we are happy to participate in further discussion on this matter.
Should FDA create working groups, workshops, or stakeholder meetings addressing GenAI-enabled medical
devices, clinical investigations, or research oversight, we are willing to participate and assist in this effort.

Sincerely,
Lauri Carlile
Chief Research Services Officer
Advarra, Inc.
443-283-1577
lauri.carlile@advarra.com

CC: Julie Ozier, Senior Vice President and Institutional Official, Regulatory; Susan Ebert, Senior IRB Chair Director; Erin
Odor, IRB Chair Manager; Jan Hewett, Senior Vice President, FDA Regulatory Advisor; Stephanie Pyle, Regulatory
Documentation Manager

Response to Docket No. FDA-2026-N-7874