[Federal Register Volume 89, Number 25 (Tuesday, February 6, 2024)]
[Notices]
[Page 8205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02361]



[[Page 8205]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0008]


Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting--FSYX Ocular Pressure Adjusting Pump 
System

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 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 March 21, 2024, from 9 
a.m. to 6 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, 
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: Akinola Awojope, 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], 301-636-0512, 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 March 21, 
2024, the committee will discuss and make recommendations on 
information related to the De Novo request by Balance Ophthalmics, Inc. 
for the safety and effectiveness of the FSYX Ocular Pressure Adjusting 
Pump (FSYX OPAP) System. The FSYX OPAP System is indicated as 
adjunctive therapy for the reduction of intraocular pressure (IOP) 
during use in adult patients with open-angle glaucoma and IOP <=21 
mmHg.
    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. Scroll down and 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 
March 5, 2024. Oral presentations from the public will be scheduled on 
March 21, 2024, between approximately 1 p.m. and 2 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 February 26, 2024. 
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 February 27, 2024.
    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/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. 1001 et seq.). This meeting notice also serves 
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 
14.22(b), (f), and (g) relating to the location of advisory committee 
meetings are hereby waived to allow for this meeting to take place 
using an online meeting platform. This waiver is in the interest of 
allowing greater transparency and opportunities for public 
participation, in addition to convenience for advisory committee 
members, speakers, and guest speakers. The conditions for issuance of a 
waiver under 21 CFR 10.19 are met.

    Dated: February 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02361 Filed 2-5-24; 8:45 am]
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