Digital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Total Product Lifecycle Considerations for Generative Artificial Intelligence-Enabled Medical Devices, 76119-76120 [2024-21074]
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Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices
Dated: September 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–20924 Filed 9–16–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3924]
Digital Health Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for
Comments—Total Product Lifecycle
Considerations for Generative Artificial
Intelligence-Enabled Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
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 on
regulatory issues. The Committee will
discuss total product lifecycle
considerations for Generative Artificial
Intelligence (AI)-enabled devices. The
meeting will be open to the public. FDA
is establishing a docket for public
comment on this topic.
DATES: The meeting will be held on
November 20–21, 2024, from 9 a.m. to
6 p.m. eastern time.
ADDRESSES: Holiday Inn Gaithersburg,
Two Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel’s
telephone number is 301–948–8900.
The hotel’s link can be found at: https://
www.ihg.com/holidayinn/hotels/us/en/
gaithersburg/wasrv/hoteldetail. Answers
to commonly asked questions including
information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2024–N–3924.
The docket will close on January 21,
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 January 21, 2025.
Comments received by mail/hand
delivery/courier (for written/paper
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SUMMARY:
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submissions) will be considered timely
if they are received on or before that
date.
Comments received on or before
November 1, 2024, 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 canceled, 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–
2024–N–3924 for ‘‘Digital Health
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
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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.
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-201509-18/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:
James Swink, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5221, Silver Spring,
MD 20993–0002, 301–796–6313,
James.Swink@fda.hhs.gov, 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
E:\FR\FM\17SEN1.SGM
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ddrumheller on DSK120RN23PROD with NOTICES1
76120
Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices
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 coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On November 20 and 21,
2024, the Committee will discuss how
the use of Generative AI may impact
safety and effectiveness of medical
devices enabled with this technology.
The Committee will discuss premarket
performance evaluation, risk
management, and postmarket
performance monitoring for Generative
AI-enabled devices.
FDA intends to make background
material 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 and the background
material will be posted on FDA’s
website after the meeting. Background
material will be available at the location
of the advisory committee meeting and
at https://www.fda.gov/Advisory
Committees/Calendar/default.htm.
Scroll down to the appropriate advisory
committee meeting link.
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 November 1,
2024, will be provided to the
Committee. Oral presentations from the
public will be scheduled November 20,
2024, between approximately 1 p.m.
and 2 p.m. Eastern Time and November
21, 2024, between approximately 9:15
a.m. and 10:45 a.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 25, 2024. 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
VerDate Sep<11>2014
17:12 Sep 16, 2024
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the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
October 26, 2024. Persons attending
FDA’s advisory committee meetings are
advised that FDA is not responsible for
providing access to electrical outlets.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
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 Ann Marie
Williams, at Annmarie.Williams@
fda.hhs.gov or 301–796–5966 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/Advisory
Committees/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.).
Dated: September 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21074 Filed 9–16–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–3163]
Considerations for Generating Clinical
Evidence From Oncology Multiregional
Clinical Development Programs; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Considerations for Generating Clinical
Evidence From Oncology Multiregional
Clinical Development Programs.’’ This
draft guidance provides
recommendations to sponsors who are
planning global clinical development
programs for drugs intended to treat
cancer, on improving the evidence
obtained from one or more
multiregional clinical trials (MRCTs)
intended to support a marketing
SUMMARY:
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application. This draft guidance
expands on principles described in
FDA’s existing guidance documents
related to this topic, by providing
additional recommendations for the
planning, design, conduct, and analysis
of an oncology MRCT that may facilitate
FDA’s assessment of applicability of the
data to the U.S. population with the
cancer being investigated and to U.S.
medical practice.
DATES: Submit either electronic or
written comments on the draft guidance
by November 18, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time 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–
E:\FR\FM\17SEN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Notices]
[Pages 76119-76120]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21074]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3924]
Digital Health Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments--Total Product
Lifecycle Considerations for Generative Artificial Intelligence-Enabled
Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
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 on regulatory issues. The
Committee will discuss total product lifecycle considerations for
Generative Artificial Intelligence (AI)-enabled devices. The meeting
will be open to the public. FDA is establishing a docket for public
comment on this topic.
DATES: The meeting will be held on November 20-21, 2024, from 9 a.m. to
6 p.m. eastern time.
ADDRESSES: Holiday Inn Gaithersburg, Two Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel's telephone number is 301-948-8900.
The hotel's link can be found at: https://www.ihg.com/holidayinn/hotels/us/en/gaithersburg/wasrv/hoteldetail. Answers to commonly asked
questions including information regarding special accommodations due to
a disability, visitor parking, and transportation 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-2024-N-3924. The docket will close on January
21, 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
January 21, 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 November 1, 2024, 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 canceled, 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-2024-N-3924 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. 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: James Swink, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5221, Silver Spring, MD 20993-0002, 301-796-6313,
[email protected], 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
[[Page 76120]]
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 coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On November 20 and 21, 2024, the Committee will discuss how
the use of Generative AI may impact safety and effectiveness of medical
devices enabled with this technology. The Committee will discuss
premarket performance evaluation, risk management, and postmarket
performance monitoring for Generative AI-enabled devices.
FDA intends to make background material 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 and the background material
will be posted on FDA's website after the meeting. Background material
will be available at the location of the advisory committee meeting and
at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll
down to the appropriate advisory committee meeting link.
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 November 1, 2024, will be provided to the Committee. Oral
presentations from the public will be scheduled November 20, 2024,
between approximately 1 p.m. and 2 p.m. Eastern Time and November 21,
2024, between approximately 9:15 a.m. and 10:45 a.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 25, 2024. 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 26,
2024. Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
[email protected] or 301-796-4540.
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 Ann Marie Williams, at [email protected] or 301-
796-5966 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.).
Dated: September 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21074 Filed 9-16-24; 8:45 am]
BILLING CODE 4164-01-P
