[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22220-22221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information on how to access the 
webcast will be made available no later than 2 business days prior to 
the meeting at https://www.fdalive.com/peac.

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, 
[email protected], 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 https://www.fda.gov/advisory-committees 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 https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee. 
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 https://www.fdalive.com/peac. 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 https://www.fdalive.com/peac.
    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

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accommodate persons with disabilities. If you require accommodations 
due to a disability, please contact AnnMarie 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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings 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