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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2022-N-0008]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# 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,                         *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 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                     *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                           ( print page 22221)                        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: 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