[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]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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