[Federal Register Volume 90, Number 175 (Friday, September 12, 2025)]
[Notices]
[Pages 44196-44197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-17651]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2338]
Digital Health Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments--Generative
Artificial Intelligence-Enabled Digital Mental Health Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Digital Health Advisory
Committee (the Committee). The general function of the Committee is to
provide advice and recommendations to FDA. The meeting will be open to
the public. FDA is establishing a docket for public comment.
DATES: The meeting will be held virtually on November 6, 2025, from 9
a.m. to 6 p.m. ET.
ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform.
Answers to commonly asked questions about FDA advisory committee
meetings, may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2025-N-2338. The docket will close on December
8, 2025. Please note that late, untimely filed comments will not be
considered. The https://www.regulations.gov electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of
December 8, 2025. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
received on or before that date.
Comments received on or before October 17, 2025, will be provided
to the Committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-2338 for ``Digital Health Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff.
[[Page 44197]]
If you do not wish your name and contact information be made publicly
available, you can provide this information on the cover sheet and not
in the body of your comments and you must identify the information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices &
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Avenue, Building 66, Room 5407, Silver Spring, MD 20993,
[email protected], 301-796-8398, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link or call the advisory committee
information line to learn about possible modifications before the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing and/or video
conferencing platform.
On November 6, 2025, the Committee will discuss and make
recommendations on the topic of ``Generative Artificial Intelligence-
Enabled Digital Mental Health Medical Devices.'' Many of these medical
devices pose novel risks and, as mental health devices continue to
evolve in complexity, regulatory approaches ideally will also evolve to
accommodate these novel challenges and opportunities to provide a
reasonable assurance of their safety and effectiveness while promoting
innovation to support public health. There is an increasing demand for
mental health services in the US and insufficient access to mental
health care providers. These new devices may be one way to help address
this gap in care for people, potentially improving outcomes and access.
The committee will discuss the benefits, risks to health, and risk
mitigations that might be considered for these new digital mental
health devices, including premarket evidence and postmarket monitoring
considerations.
FDA intends to make background material and the link to the live
webcast available to the public no later than (2) business days before
the meeting. If FDA is unable to post the background material on its
website prior to the meeting, the background material will be made
publicly available on FDA's website at the time of the advisory
committee meeting. Background materials and the link to the online
teleconference and/or video conference meeting will be available at
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link.
The meeting will include slide presentations with audio and video
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions to the Docket (see ADDRESSES) on
or before October 17, 2025, will be provided to the Committee. Oral
presentations from the public will be scheduled between approximately
between 10:30 a.m. and 12:30 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before October 9, 2025. Time
allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 10, 2025.
For press inquiries, please contact the HHS Press Room at
www.hhs.gov/press-room/index.html or 202-690-6343. FDA welcomes the
attendance of the public at its advisory committee meetings and will
make every effort to accommodate persons with disabilities. If you
require accommodations due to a disability, please contact CDR Daniel
Bailey, M.S., M.B.A, M.DIV, at [email protected] or 301-529-
54505 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. The conditions for issuance of a
waiver under 21 CFR 10.19 are met.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-17651 Filed 9-11-25; 8:45 am]
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