[Federal Register Volume 63, Number 138 (Monday, July 20, 1998)]
[Notices]
[Page 38838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19175]
[[Page 38838]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Gastroenterology and Urology 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: Gastroenterology and Urology 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 July 30, 1998, 9:30 a.m.
to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: Mary J. Cornelius, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2194, ext. 118, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12523. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The committee will discuss: (1) Reclassification of
extracorporeal shock wave lithotriptors indicated for the fragmentation
of kidney and ureteral calculi, (2) revised clinical and preclinical
performance testing requirements, and (3) labeling.
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 July 23, 1998.
Oral presentations from the public will be scheduled between
approximately 9:30 a.m. and 10 a.m. Near the end of the committee
deliberations, a 30-minute open public session will be conducted for
interested persons to address issues specific to the FDA proposed
reclassification before the committee. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 23, 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).
FDA regrets that it was unable to publish this notice 15 days prior
to the Gastroenterology and Urology Devices Panel of the Medical
Devices Advisory Committee meeting. Because the agency believes there
is some urgency to bring these issues to public discussion and
qualified members of the Gastroenterology and Urology Devices Panel of
the Medical Devices Advisory Committee were available at this time, the
Commissioner concluded that it was in the public interest to hold this
meeting even if there was not sufficient time for the customary 15-day
public notice.
Dated: July 10, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-19175 Filed 7-17-98; 8:45 am]
BILLING CODE 4160-01-F
