Notice2022-08013
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
April 14, 2022
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 CDRH Patient Engagement Advisory 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 87 Issue 72 (Thursday, April 14, 2022)</title>
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[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22220-22221]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08013]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-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) announces a forthcoming
public advisory committee meeting of the CDRH Patient Engagement
Advisory 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 July 12, 2022, from 10
a.m. to 4 p.m. Eastern Time and on July 13, 2022, from 10 a.m. to 2
p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing 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.fdalive.com/peac">https://www.fdalive.com/peac</a>.
FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#95f9f0e1fce6f0bbe2fcf9f9fcf4f8e6d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="0d616879647e68237a646161646c607e4d6b696c2365657e236a627b">[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 July 12
and 13, 2022, the committee will discuss and make recommendations on
the topic of ``Augmented Reality (AR) and Virtual Reality (VR) Medical
Devices.'' AR/VR devices are increasingly applied to healthcare
settings across the patients' care continuum. From diagnostics to
clinical decision making, to surgical support, and to directly treating
patients, AR/VR devices are used across multiple medical specialties.
These devices have novel attributes and considerations for the end
users that impact FDA's evaluation of the device's safety and
effectiveness. The novel attributes of digital health visualization,
tracking techniques, embedded software among other factors present
unique challenges for pre- and postmarked evaluation. The
recommendations provided by the committee will address factors FDA and
industry should consider when evaluating the benefits, risks, and the
extent of uncertainty in the benefit-risk information for AR/VR medical
devices. The committee will also consider specific challenges related
to specific populations (e.g., pediatric or cognitively impaired) who
may use this technology. Additionally, the committee will discuss ways
patient perspectives could be incorporated in FDA and industry benefit-
risk decision making, as well as the healthcare provider decision-
making process related to using or prescribing the technology.
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
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 2022 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.
Oral presentations from the public will be scheduled on July 12, 2022,
between approximately 2:30 p.m. Eastern Time to 3:30 p.m. Eastern Time.
Those individuals interested in making formal oral presentations should
notify the contact person (see FOR FURTHER INFORMATION CONTACT). 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 on or before June 10, 2022. 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 June 14, 2022. Individuals
who do not wish to speak at the open public hearing session but would
like their comments to be heard by the committee may send written
submissions to the contact person on or before June 20, 2022.
Virtual Breakout Session: Individuals interested in participating
in the virtual breakout scenario discussions will need to sign up to
participate on or before June 28, 2022. The signup sheet, as well as
additional information pertaining to the virtual scenario discussions,
will be available at <a href="https://www.fdalive.com/peac">https://www.fdalive.com/peac</a>. Everyone who signs
up in advance and provides a valid email address will receive an email
at least 2 days prior to the meeting with information on how to access
the virtual platform that will host the virtual breakout scenario
discussions. Please note that due to limited technology capacity,
participation in the virtual breakout scenario discussions will be
limited to 150 participants. Once capacity reaches 150 participants,
the breakout session will be closed to additional participants.
Additional information regarding the virtual breakout scenario
discussions will be provided at <a href="https://www.fdalive.com/peac">https://www.fdalive.com/peac</a>.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#3d5b595c52505c7d5b595c1355554e135a524b"><span class="__cf_email__" data-cfemail="096f6d68666468496f6d682761617a276e667f">[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
[[Page 22221]]
accommodate persons with disabilities. If you require accommodations
due to a disability, please contact AnnMarie Williams at
<a href="/cdn-cgi/l/email-protection#01406f6f6c607368642f56686d6d68606c72416765602f6969722f666e77"><span class="__cf_email__" data-cfemail="fcbd9292919d8e9599d2ab959090959d918fbc9a989dd294948fd29b938a">[email protected]</span></a>, 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 <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. Please be advised that, during the virtual
scenario breakout discussions, FDA will prepare a summary of the
discussion in lieu of detailed transcripts.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08013 Filed 4-13-22; 8:45 am]
BILLING CODE 4164-01-P
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