Notice2023-10609
Patient Engagement Advisory Committee; Notice of Meeting
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
May 18, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Center for Devices and Radiological Health (CDRH) Patient Engagement Advisory Committee (the Committee). The general function of the committee is to provide advice to the Commissioner of Food and Drugs, or designee, on complex scientific issues relating to medical devices, the regulation of devices, and their use by patients. The meeting will be open to the public.
Full Text
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<title>Federal Register, Volume 88 Issue 96 (Thursday, May 18, 2023)</title>
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[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Notices]
[Pages 31767-31768]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-10609]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0008]
Patient Engagement Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) announces
a forthcoming public advisory committee meeting of the Center for
Devices and Radiological Health (CDRH) Patient Engagement Advisory
Committee (the Committee). The general function of the committee is to
provide advice to the Commissioner of Food and Drugs, or designee, on
complex scientific issues relating to medical devices, the regulation
of devices, and their use by patients. The meeting will be open to the
public.
DATES: The meeting will take place virtually on September 6, 2023, from
10 a.m. to 5:20 p.m. Eastern Time.
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: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>. Information on how to access the
webcast will be made available no later than 2 business days prior to
the meeting at <a href="https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee">https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee</a>. Select the
link for the 2023 Meeting Materials.
FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5407, Silver Spring,
[[Page 31768]]
MD 20993-0002, <a href="/cdn-cgi/l/email-protection#18747d6c716b7d366f7174747179756b587e7c793670706b367f776e"><span class="__cf_email__" data-cfemail="bfd3dacbd6ccda91c8d6d3d3d6ded2ccffd9dbde91d7d7cc91d8d0c9">[email protected]</span></a>, 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 the Agency's website
at <a href="https://www.fda.gov/advisory-committees">https://www.fda.gov/advisory-committees</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 platform. On September
6, 2023, the Committee will discuss and make recommendations on the
topic of ``Advancing Health Equity in Medical Devices.'' FDA CDRH is
committed to working toward ensuring that all patients have access to
high-quality, safe, and effective medical devices. This includes
ensuring devices are designed to be safe and effective when used by
various populations, are evaluated in the diverse populations for which
they are intended, and that patients and consumers have the information
they need to make decisions about their health, care and quality of
life. Technology, including digital health technology, may help bridge
gaps in health equity by extending access and bringing healthcare to
patients at home, at work, and in their communities. The
recommendations provided by the committee will address considerations
for FDA and industry on these topics. The Committee will consider ways
to advance access to devices that allow for care outside a hospital or
clinical care setting--for example, in the home setting. The Committee
will also discuss considerations for improving reach and comprehension
of FDA's patient and caregiver communications across diverse
demographic groups. Additionally, the Committee will discuss patient-
focused considerations for when a device should be evaluated in diverse
populations to support marketing authorization.
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 materials
and the link to the online teleconference meeting room will be
available at <a href="https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee">https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee</a>. Select the
link for the 2023 Meeting Materials. The meeting will include slide
presentations with audio 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.
Written submissions may be made to the contact person (see FOR FURTHER
INFORMATION CONTACT) on or before August 10, 2023. Oral presentations
from the public will be scheduled on September 6, 2023, between
approximately 2:15 p.m. to 3:15 p.m. Eastern Time. Those individuals
interested in making formal oral presentations should notify the
contact person on or before August 2, 2023. The notification should
include 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. 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 August 3,
2023.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#dabcbebbb5b7bb9abcbebbf4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="593f3d38363438193f3d387731312a773e362f">[email protected]</span></a> 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 AnnMarie Williams at <a href="/cdn-cgi/l/email-protection#a0e1cececdc1d2c9c58ef7c9ccccc9c1cdd3e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="d293bcbcbfb3a0bbb7fc85bbbebebbb3bfa192b4b6b3fcbabaa1fcb5bda4">[email protected]</span></a>, or 240-507-
6496 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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings">https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings</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. app. 2).
Dated: May 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10609 Filed 5-17-23; 8:45 am]
BILLING CODE 4164-01-P
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