[Federal Register Volume 85, Number 168 (Friday, August 28, 2020)]
[Notices]
[Pages 53382-53383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18953]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-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) is announcing a 
forthcoming public advisory committee meeting of the Patient Engagement 
Advisory Committee. The general function of the committee is to provide 
advice to the Commissioner, or designee, on complex 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 October 22, 2020, from 
10 a.m. Eastern Time to 5 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 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, 
letise.williams@fda.hhs.gov, 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.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. On October 
22, 2020, the committee will discuss and make recommendations on the 
topic ``Artificial Intelligence (AI) and Machine Learning (ML) in 
Medical Devices.'' Specifically, we will discuss the composition of the 
datasets on which the software ``learns'', components of the device 
information shared with patients, and factors that impact patient trust 
in the technology. Large clinical datasets are used to train and 
improve AI/ML algorithms, allowing transformational improvements in the 
diagnosis, clinical decision making, and treatment of patients. Devices 
using AI/ML technology will transform healthcare delivery by increasing 
efficiency of key processes in the treatment of patients. Health 
products powered by AI/ML are streaming into our lives, from virtual 
doctor apps to wearable sensors and drugstore chatbots to algorithms 
for detecting cancer in mammography and interpretations of chest X 
rays. Despite the rapid advancement and integration, AI/ML systems may 
have algorithmic biases, limited generalizability, and lack 
transparency in their assumptions based on potential limitations of 
training datasets. The recommendations provided by the committee will 
address the importance of including various demographic groups in AI/ML 
algorithm development. The recommendations will also address the impact 
of the user interface and transparency including what information and 
how the information about the devices could be communicated to foster 
patient trust in the AI/ML 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 materials 
will be available at https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee. 
Select the link for the 2020 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

[[Page 53383]]

from the public will be scheduled on October 22, 2020, between 
approximately 1:30 p.m. Eastern Time to 2:30 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 September 22, 2020. 
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 September 24, 2020. 
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 September 30, 
2020.

Virtual Breakout Session:

    Individuals interested in participating in the virtual breakout 
scenario discussion will need to signup to participate on or before 
October 8, 2020. The signup sheet, as well as, additional information 
pertaining to the virtual scenario discussion will be available at 
https://www.fdalive.com/peac/. Please note due to limited technology 
capacity, participation in the virtual breakout scenario discussion 
will be limited to 150 participants. The first 150 participants to sign 
up for the virtual breakout scenario discussion will receive a Zoom 
access link that will provide them with access to their assigned 
breakout room. Participants will receive the Zoom link no later than 2 
days prior to the meeting. Individuals participating in the virtual 
breakout scenario discussion will only have access to Zoom during the 
time of the virtual breakout scenario discussion. Participants will 
need to sign out of the webcast and log into the Zoom at the time of 
the virtual breakout scenario discussion. Once the virtual breakout 
scenario discussion concludes participants will be signed out from Zoom 
and will need to log back into the webcast to participate in the 
remainder of the meeting.
    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 AnnMarie 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/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: August 21, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-18953 Filed 8-27-20; 8:45 am]
BILLING CODE 4164-01-P


