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| Name of Committee | Ophthalmic Devices Panel |
| Date and Time | The meeting was held on the following dates:
Feb 5, 04 9:00 AM - 5:00 PM
Feb 6, 04 8:00 AM - 4:30 PM
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| Location | Gaithersburg Marriott, Salons A,B,C and D
9751 Washingtonian Blvd.
Gaithersburg
, MD |
| Contact Information | 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. Information can be found on the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512396. Please call the Information Line or access this Internet page for up-to-date information on this meeting. (E-mail contact smt@cdrh.fda.gov) |
| 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 information for each day’s topic, including the attendee list, agenda, and questions for the committee, will be available to the public one business day before the meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the February 5 session will be posted on February 4, 2004; material for the February 6 session will be posted on February 5, 2004. |
| 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 9:15 a.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. |
| Closed Committee Information | On February 6, 2004, from 8 a.m. to 9:30 a.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)). |
| | Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. |
| Conduct | FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings. |
| Related Documents | |
| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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