Notice2024-02361
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting-FSYX Ocular Pressure Adjusting Pump System
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 25 (Tuesday, February 6, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 25 (Tuesday, February 6, 2024)]
[Notices]
[Page 8205]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02361]
[[Page 8205]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
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,
<a href="/cdn-cgi/l/email-protection#2b6a40424544474a056a5c4441445b4e6b4d4f4a05434358054c445d"><span class="__cf_email__" data-cfemail="296842404746454807685e464346594c694f4d480741415a074e465f">[email protected]</span></a>, 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. 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
<a href="/cdn-cgi/l/email-protection#dbbdbfbab4b6ba9bbdbfbaf5b3b3a8f5bcb4ad"><span class="__cf_email__" data-cfemail="d6b0b2b7b9bbb796b0b2b7f8bebea5f8b1b9a0">[email protected]</span></a> 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 <a href="/cdn-cgi/l/email-protection#fabb9494979b88939fd4ad939696939b9789ba9c9e9bd4929289d49d958c"><span class="__cf_email__" data-cfemail="266748484b47544f4308714f4a4a4f474b5566404247084e4e5508414950">[email protected]</span></a> 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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> 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]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 6, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.