[Federal Register Volume 63, Number 19 (Thursday, January 29, 1998)]
[Notices]
[Page 4458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2264]
[[Page 4458]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Microbiology Devices Panel, the Clinical
Chemistry and Clinical Toxicology Devices Panel, the Hematology and
Pathology Devices Panel, and the Immunology 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: Joint meeting of the Microbiology Devices Panel,
the Clinical Chemistry and Clinical Toxicology Devices Panel, the
Hematology and Pathology Devices Panel, and the Immunology 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 February 11, 1998, 11
a.m. to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: Freddie M. Poole, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-2096, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12517. Please call the Information Line for
up-to-date information on this meeting.
Agenda: The committee will provide advice and recommendations to
the agency on issues concerning appropriate data collection, analysis,
and resolution of discrepant results, using sound scientific and
statistical analysis to support indications for use of in vitro
diagnostic devices. After hearing a series of presentations on the
subject, the committee will discuss appropriate recommended analysis of
data when the new device is compared to another device, a recognized
reference method or ``gold standard,'' other procedures not commonly
used, and/or clinical criteria for diagnosis. The committee will be
asked: (1) How the FDA should proceed in this area of discrepant
resolution when new technology such as nucleic acid amplification is
perceived to be more accurate than the reference or ``gold standard''
methods, (2) for guidance to implement their recommendations, and (3)
for the appropriate approach to address these issues in the product
labeling (package insert). These draft questions proposed for
discussion may be subject to modifications or additions prior to the
advisory committee meeting. FDA will consider these recommendations in
the future development of review criteria for the collection and
analysis of data to support the indications for use of in vitro
diagnostic 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 January 28,
1998. Oral presentations from the public will be scheduled between
approximately 1:45 p.m. and 2:45 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before January 28, 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.
FDA regrets that it was unable to publish this notice 15 days prior
to the February 11, 1998, Joint meeting of the Microbiology Devices
Panel, the Clinical Chemistry and Clinical Toxicology Devices Panel,
the Hematology and Pathology Devices Panel, and the Immunology 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 Joint meeting of the
Microbiology Devices Panel, the Clinical Chemistry and Clinical
Toxicology Devices Panel, the Hematology and Pathology Devices Panel,
and the Immunology 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: January 23, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-2264 Filed 1-26-98; 4:24 pm]
BILLING CODE 4160-01-F