Document ID: FDA-2014-N-0001-0044
Agency: fda
Document Type: Notice
Title: Ophthalmic Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting
Posted Date: 2014-05-12T04:00Z

[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Notices]
[Page 26973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10803]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Ophthalmic Devices Panel of the Medical Devices 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 6, 2014, from 8 
a.m. to 6 p.m.
    Location: Hilton Washington, DC North/Gaithersburg, salons A, B, C, 
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone 
number is 301-977-8900.
    Contact Person: Natasha Facey, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 1552, Silver Spring, MD 20993, 301-796-5290, 
Natasha.Facey@fda.hhs.gov, 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 Web site at http://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 coming to 
the meeting.
    Agenda: On June 6, 2014, the committee will discuss, make 
recommendations, and vote on information related to the premarket 
approval application for the KAMRA Inlay (Model ACI 7000) (KAMRA Inlay) 
submitted by applicant AcuFocus, Inc. The KAMRA Inlay is a permanent 
corneal implant that is placed intrastromally in a corneal pocket or 
under a corneal flap. The opaque annulus of the inlay reduces the 
aperture of the eye, which improves near vision by providing an 
increased depth of focus in the implanted eye. The proposed indication 
for use states that the KAMRA Inlay is indicated for the improvement of 
near and intermediate vision in presbyopic patients who require near or 
intermediate correction. The KAMRA Inlay is intended to be placed 
intrastromally in the cornea, on the visual axis, by way of a 
femtosecond laser-created pocket using a spot/line separation of 6x6 
microns ([micro]) or less. The KAMRA Inlay should be placed at a depth 
equal to or greater than 180 [micro].
    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 Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    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 May 
30, 2014. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on June 6, 2014. 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 May 21, 2014. 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 May 27, 2014.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact James Clark at 
James.Clark@fda.hhs.gov or 301-796-5293 at least 7 days in advance of 
the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://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: May 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10803 Filed 5-9-14; 8:45 am]
BILLING CODE 4160-01-P