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| Center | Date | Time | Location |
|---|---|---|---|
| CDRH | February 05, 2004 February 06, 2004 |
9 a.m. - 5 p.m. 8 a.m. - 4:30 p.m. |
Gaithersburg Marriott |
Agenda:
On February 5, 2004, the committee will discuss, make recommendations, and vote
on a premarket approval application (PMA) for a phakic intraocular lens for
the reduction or elimination of myopia in adults.
On February 6, 2004, the committee will discuss, make recommendations and vote on a PMA for a radiofrequency electrosurgical corneal shaping device for the temporary treatment of presbyopia.
Background material and meeting information will become available no later than the day before the meeting (Simply scroll down to the appropriate committee link). Material for the February 5, 2004, session will be posted on February 4, 2004; material for the February 6, 2004, session will be posted on February 5, 2004.
Closed Committee Deliberations:
On February 6, 2004, from 8 a.m. to 9:30a.m., the meeting will be closed to
permit FDA staff to present to the committee trade secret and/or confidential
commercial information relevant to pending and future device submissions for
vitreoretinal, surgical and diagnostic devices, intraocular and corneal implants,
and contact lenses. This portion of the meeting will be closed to permit discussion
of this information (5 U.S.C.552b(c)(4)).
Procedure:
On February 5, 2004, from 9 a.m. to 5 p.m., and on February 6, 2004, from 9:30
a.m. to 4:30 p.m., the meeting is open to the public. 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
by January 26, 2004. On February 5, 2004, formal oral presentations from the
public will be scheduled between approximately 9:15a.m. and 9:45 a.m. Near the
end of the committee deliberations on the PMA, a 30-minute open public session
will be conducted for interested persons to address issues specific to the submission
before the committee. On February 6, 2004, oral presentations from the public
will be scheduled between approximately 9:45 a.m. and 10:15 a.m. Near the end
of committee deliberations on the PMA, a 30-minute open public session will
be conducted for interested persons to address issues specific to the submission
before the committee. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact person
before January 26, 2004 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. 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 301-594-1283,
ext. 113, at least 7 days in advance of the meeting.
Contact Person:
Sara M. Thornton, Center for Devices and Radiological Health (HFZ-460), Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2053,
ext. 127, 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.