[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61091-61092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21831]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Ophthalmic Devices Panel of the Medical Devices 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 Agency) announces a 
forthcoming public advisory committee meeting of the Ophthalmic Devices 
Panel of the Medical Devices Advisory Committee. The general function 
of the committee is to provide advice and recommendations to the Agency 
on FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will take place virtually on November 10, 2022, from 
9 a.m. 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 including information regarding special 
accommodations due to a disability may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Jarrod Collier, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002, 
[email protected], 240-672-5763, 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/AdvisoryCommittees/default.htm 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 November 
10, 2022, the committee will discuss and make recommendations on the 
classification of ophthalmic dispensers, which are currently 
unclassified pre-amendment devices to class I (general controls). This 
will include a discussion of the known risks and safety/effectiveness 
concerns and a general classification recommendation for ophthalmic 
dispensers.
    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 material 
and the link to the online teleconference meeting room will be 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Select the appropriate advisory committee meeting link. 
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 on or before 
October 20, 2022. Oral presentations from the public will be scheduled 
on November 10, 2022, between approximately 9:15 a.m. and 10:15 a.m. 
Eastern Time. Those individuals interested in making formal oral 
presentations should notify the contact person and submit 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 October 12, 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 October 
13, 2022.
    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

[[Page 61092]]

accommodate persons with disabilities. If you require accommodations 
due to a disability, please contact Artair Mallett at 
[email protected] or 301-796-9638 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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: October 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21831 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P


