[Federal Register Volume 63, Number 147 (Friday, July 31, 1998)]
[Notices]
[Pages 40912-40913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20467]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Radiological 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.
[[Page 40913]]
Name of Committee: Radiological 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 August 17, 1998, 9 a.m.
to 5 p.m., and August 18, 1998, 8 a.m. to 4 p.m.
Location: Corporate Bldg., 9200 Corporate Blvd., conference room
020B, Rockville, MD.
Contact Person: Robert J. Doyle, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1212, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12526. Please call the Information Line for
up-to-date information on this meeting.
Agenda: On the morning of August 17, 1998, the committee will
discuss, make recommendations, and vote on a premarket approval
application (PMA) for an image analysis software tool for interproximal
caries detection. On the afternoon of August 17, 1998, the committee
will discuss, make recommendations, and vote on a PMA for a trans-
spectral impedance scanner for use in detecting breast cancer. On
August 18, 1998, the committee will discuss and make recommendations on
changes to the existing guidance document on digital mammography
devices. Single copies of the guidance document entitled ``Information
for Manufacturers Seeking Marketing Clearance of Digital Mammography
Systems'' can be obtained by contacting the Division of Small
Manufacturers Assistance, 1350 Piccard Dr., Rockville, MD 20851, 1-800-
638-2041 or 301-443-6597 or on the Internet ``http://www.fda.gov/cdrh/
ode/digmammo.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 August 7,
1998. On August 17, 1998, oral presentations from the public will be
scheduled between approximately 9:15 a.m. and 9:45 a.m., 1:15 p.m. and
1:45 p.m., and for an additional 30 minutes near the end of the
committee deliberations on each of the two agenda items. On August 18,
1998, oral presentations from the public will be scheduled between
approximately 8:15 a.m. and 8:45 a.m., and for an additional 30 minutes
near the end of the committee deliberations. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before August 11, 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: July 24, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-20467 Filed 7-30-98; 8:45 am]
BILLING CODE 4160-01-F
