Notice2025-20608
General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice-Establishment of Public Docket; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 21, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing an amendment to the notice of the meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee (the Committee). This meeting was previously announced in the Federal Register of September 3, 2025. The amendment is being made to reflect changes in the DATES, ADDRESSES and SUPPLEMENTARY INFORMATION portions of the document. There are no other changes.
Full Text
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<title>Federal Register, Volume 90 Issue 223 (Friday, November 21, 2025)</title>
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[Federal Register Volume 90, Number 223 (Friday, November 21, 2025)]
[Notices]
[Pages 52680-52681]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20608]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0008]
General Hospital and Personal Use Devices Panel of the Medical
Devices Advisory Committee; Amendment of Notice--Establishment of
Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of the meeting of the General Hospital and
Personal Use Devices Panel of the Medical Devices Advisory Committee
(the Committee). This meeting was previously announced in the Federal
Register of September 3, 2025. The amendment is being made to reflect
changes in the DATES, ADDRESSES and SUPPLEMENTARY INFORMATION portions
of the document. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Evella Washington, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg., 66, Rm. 2404, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#c287b4a7aeaea3ec95a3b1aaabaca5b6adac82a4a6a3ecaaaab1eca5adb4"><span class="__cf_email__" data-cfemail="a0e5d6c5ccccc18ef7c1d3c8c9cec7d4cfcee0c6c4c18ec8c8d38ec7cfd6">[email protected]</span></a>, 240-447-9160.
SUPPLEMENTARY INFORMATION: In the Federal Register of September 3, 2025
(90 FR 42588), FDA announced that a meeting of the General Hospital and
Personal Use Devices Panel of the Medical Devices Advisory Committee
would be held on October 8, 2025. On page 42588, in the third column,
``The meeting will be held virtually on October 8, 2025, from 9 a.m. to
3:30
[[Page 52681]]
p.m. Eastern Time'', the DATES portion of the document is changed to
read as follows:
The meeting will be held virtually on December 10, 2025, from 9
a.m. to 3:30 p.m. Eastern Time.
On page 42588, in the third column to page 42589, in the first
column ``FDA is establishing a docket for public comment on this
meeting. The docket number is FDA-2025-N-0008. The docket will close on
November 10, 2025. Please note that late, untimely filed comments will
not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
November 10, 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 September 24, 2025, will be provided
to the Committee. Comments received after this date will be taken into
consideration by FDA. The ADDRESSES portion of the document is changed
to read as follows:
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2025-N-0008. The docket will close on January
9, 2026. Please note that late, untimely filed comments will not be
considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of
January 9, 2026. 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 December 1, 2025, will be provided
to the Committee. Comments received after this date will be taken into
consideration by FDA.
On page 42589, in the third column, Agenda: On October 8, 2025, the
SUPPLEMENTARY INFORMATION portion of the document is changed to read as
follows:
Agenda: On December 10, 2025.
On page 42589, in the third column to page 42590, in the first
column, ``Interested persons may present data, information, or views,
orally or in writing, on issues pending before the Committee. All
electronic and written submissions made to the Docket (see ADDRESSES)
on or before September 24, 2025, will be provided to the Committee.
Oral presentations from the public will be scheduled between
approximately 11:30 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 September 18, 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 September 22, 2025. The
SUPPLEMENTARY INFORMATION portion of the document is changed to read as
follows:
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
All electronic and written submissions made to the Docket (see
ADDRESSES) on or before December 1, 2025, will be provided to the
Committee. Oral presentations from the public will be scheduled on
December 10, 2025, between approximately 11:30 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 December 3, 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 December
3, 2025.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14, relating to the advisory
committees.
Lowell M. Zeta,
Deputy Commissioner of Strategic Initiatives, Acting, Deputy
Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-20608 Filed 11-20-25; 8:45 am]
BILLING CODE 4164-01-P
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