    [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