[Federal Register Volume 63, Number 88 (Thursday, May 7, 1998)]
[Notices]
[Page 25214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12170]
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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 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
