Document ID: FDA-2008-N-0038-0018
Agency: fda
Document Type: Notice
Title: Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2008-03-24T04:00Z

[Federal Register: March 24, 2008 (Volume 73, Number 57)]
[Notices]               
[Page 15530]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr08-78]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
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 April 24 and 25, 2008, 
from 8:30 a.m. to 5 p.m.
    Location: Gaithersburg Holiday Inn, Ballroom, 2 Montgomery Village 
Ave., Gaithersburg, MD.
    Contact Person: Karen F. Warburton, Center for Devices and 
Radiological Health, Food and Drug Administration, 9200 Corporate 
Blvd., Rockville, MD 20850, 240-276-4238, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512396. Please call the Information Line for up-to-date 
information on this meeting. 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 
and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On April 24, 2008, the committee will discuss, make 
recommendations, and vote on a premarket approval application, 
sponsored by VisionCare Technologies, Inc., for an implantable 
miniature telescope (IMT). The IMT, a visual prosthetic device, is 
indicated for monocular implant in patients with stable, moderate to 
profound central vision impairment due to bilateral central scotomas 
associated with end-stage macular degeneration with geographic atrophy 
or disciform scar, foveal involvement, and cataract. On April 25, 2008, 
the committee will discuss general issues concerning the post market 
experience with phakic intraocular lenses and laser-assisted in situ 
keratomileusis (LASIK).
    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/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
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 
April 15, 2008. Oral presentations from the public will be scheduled on 
April 24, 2008, between approximately 9:30 a.m. and 10 a.m. and between 
approximately 3:30 p.m. and 4 p.m.; and on April 25, 2008, between 
approximately 10 a.m. and 11:15 a.m. and between approximately 3 p.m. 
and 4 p.m. Those desiring to make 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 
April 7, 2008. 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 April 8, 2008.
    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 AnnMarie Williams, 
Conference Management staff, at 240-276-8932, 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/oc/advisory/
default.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: March 14, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-5810 Filed 3-21-08; 8:45 am]

BILLING CODE 4160-01-S