Notice2026-16245
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-GRAIL, Inc. Galleri
Primary source
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Published
August 10, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Molecular and Clinical Genetics Panel of the Medical Devices 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.
Full Text
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<title>Federal Register, Volume 91 Issue 152 (Monday, August 10, 2026)</title>
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[Federal Register Volume 91, Number 152 (Monday, August 10, 2026)]
[Notices]
[Pages 51496-51498]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-16245]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-8004]
Molecular and Clinical Genetics Panel of the Medical Devices
Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments--GRAIL, Inc. Galleri
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 Molecular and Clinical
Genetics Panel of the Medical Devices 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 on September 23, 2026, from 9 a.m. to 6
p.m. Eastern Time.
ADDRESSES: The public will have the option to participate, and all
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, including information regarding special
accommodations due to a disability, visitor parking, and transportation
may be accessed at: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
The online web conference meeting will be available at the
following link on the day of the meeting at: <a href="https://youtube.com/live/83XzLN7Dbg4?feature=share">https://youtube.com/live/83XzLN7Dbg4?feature=share</a>.
The address for in-person attendance is FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993-0002.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2026-N-8004. The docket will close on
September 16, 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
September 16, 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 September 8, 2026, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
[[Page 51497]]
<bullet> 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.
<bullet> 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.
[Insert Docket Number] for ``Molecular and Clinical Genetics Panel of
the Medical Devices Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments-GRAIL, Inc.
Galleri.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both
copies to the Dockets Management Staff. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Evella Washington, Advisory Committee
Oversight Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, Rm. 3214, Silver Spring, MD 20993-0002, 301-
796-6683, <a href="/cdn-cgi/l/email-protection#367572647e697b72777576505257185e5e4518515940"><span class="__cf_email__" data-cfemail="11525543594e5c555052517775703f7979623f767e67">[email protected]</span></a>. 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
<a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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 September 23, 2026, the Committee will meet in an open session
to discuss, make recommendations, and vote on information regarding the
premarket approval application (PMA) for the Galleri[supreg] test
sponsored by GRAIL, Inc. The proposed indications for use statement is
as follows: The Galleri[supreg] test is a qualitative, next-generation
sequencing (NGS)-based in vitro diagnostic test intended to detect
cancer-specific methylation patterns in cell-free DNA isolated from
peripheral whole blood. The Galleri[supreg] test is intended for
screening for the early detection of multiple types of cancer, in
adults aged 50 years or older. The test is also intended for the
prediction of Cancer Signal Origin in individuals with a Cancer Signal
Detected test result. A test result of Cancer Signal Detected,
including a predicted Cancer Signal Origin, may indicate the presence
of an invasive solid tumor or hematologic malignancy and should be
followed by a diagnostic workup recommended by qualified healthcare
professionals. A test result of No Cancer Signal Detected does not rule
out the presence of cancer, and individuals should continue with
guideline-recommended single-cancer screening tests. This test is
performed at GRAIL, Inc. Prescription only.
FDA intends to make background material available to the public no
later than two (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
material and the link to the online teleconference and/or video
conference meeting will be available at <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. Scroll down to the appropriate
advisory committee meeting link.
The meeting will include an online meeting platform in conjunction
with the physical meeting room (see ADDRESSES) and slide presentations
with audio and video components to allow the presentation of materials
at the 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 September 8, 2026, will be provided to the Committee. Oral
presentations from the public will be scheduled between approximately
1:00 p.m. and 2:00 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, whether they would like to present online or in-person,
and an indication of the approximate time requested to make their
presentation on or before August 28, 2026. 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.
Similarly, room for interested persons to participate in-person may be
limited. If the number of registrants requesting to speak in-person
during the open public hearing is greater than can be reasonably
accommodated in the venue for the in-person portion of the advisory
committee meeting, FDA may conduct a lottery to determine the speakers
who will be invited to participate in-person. The contact person will
notify interested persons regarding their request to speak by August
31, 2026. Persons attending FDA's advisory committee meetings are
advised that FDA is not responsible for providing access to electrical
outlets.
[[Page 51498]]
For press inquiries, please contact the HHS Press Room at <a href="https://www.hhs.gov/press-room/index.html">https://www.hhs.gov/press-room/index.html</a> 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 Evella Washington <a href="/cdn-cgi/l/email-protection#4e0d0a1c0611030a0f0d0e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="672423352f382a23262427010306490f0f1449000811">[email protected]</span></a> (see FOR FURTHER
INFORMATION CONTACT) 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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> 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 in conjunction with the physical
meeting room (see ADDRESSES). 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. 2026-16245 Filed 8-7-26; 8:45 am]
BILLING CODE 4164-01-P
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