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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 March 5, 2004, from 9 a.m. to 4 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A and B, 620 Perry Pkwy., Gaithersburg, MD.

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.

Agenda: The committee will discuss general issues surrounding the use of intraocular lenses for correction of presbyopia after clear lens extraction. The committee will address clinical study design elements including the risk/benefit ratio for patients with various refractive errors, study sample size, the need for control groups, inclusion/exclusion criteria, and the incidence of retinal detachment and other complications. Background information, including the attendee list, agenda, and questions for the committee, will be available to the public 1 business day before the meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html .

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 by February 24, 2004. On March 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 discussion a second 30-minute open public session will be conducted for interested persons to comment further on the discussion topic. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 24, 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 at 301-594-1283, ext. 113 at least 7 days in advance of the meeting.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).