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

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 regulatory issues.

Date and Time: The meeting will be held on June 5, 1998, 9 a.m. to

5 p.m.

Location: Corporate Bldg., conference room 020B, 9200 Corporate

Blvd., Rockville, 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, or FDA Advisory

Committee Information Line, 1-800-741-8138 (301-443-0572 in the

Washington, DC area), code 12396, or the World Wide Web (WWW) at http:/

/www.fda.gov. Please call the Information Line for up-to-date

information on this meeting.

Agenda: The committee will discuss, make recommendations, and vote

on a premarket approval application (PMA) for an excimer laser for the

correction of myopia using laser in-situ keratomileusis. FDA staff will

present to the committee the clinical requirements section of the

proposed International Standards Organization standard for ophthalmic

viscosurgical devices.

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 May 29, 1998.

Oral presentations from the public will be scheduled between

approximately 9:30 a.m. and 10 a.m., and between approximately 1 p.m.

and 1:30 p.m. An additional 30-minute time period will be given for

public comment at the end of the panel discussion on the PMA. Time

allotted for each presentation may be limited. Those desiring to make

formal oral presentations should notify the contact person before May

29, 1998, 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.

Notice of this meeting is given under the Federal Advisory

Committee Act (5 U.S.C. app. 2).

Dated: April 30, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98-12170 Filed 5-6-98; 8:45 am]

BILLING CODE 4160-01-F