[Federal Register Volume 88, Number 96 (Thursday, May 18, 2023)]
[Notices]
[Pages 31767-31768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 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.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee. 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, [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 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 https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee. 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 
[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 AnnMarie Williams at [email protected], 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 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.
    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


