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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive
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Name of CommitteeImmunology Devices Panel
Date and TimeThe meeting was held on the following dates:
Nov 16, 2006 8:00 AM - 5:00 PM
LocationHoliday Inn, Walker/Whetstone Rooms
Two Montgomery Village Ave.
Gaithersburg , MD
Contact InformationRufina Carlos, Office of In Vitro Diagnostic Device Evaluation and Safety (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD. 20850, 240- 276-0493 ext 167, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512516. Please call the Information Line for up-to-date information on this meeting.
AgendaThe committee will discuss, make recommendations, and vote on a premarket approval application for a laboratory assay designed for the rapid detection of clinically relevant (greater than 0.2 millimeters) metastases in lymph node tissue removed from breast cancer patients. Results from the assay can be used to guide the surgeon’s decision to excise additional lymph nodes and aid in staging. Background information for the topic, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the Internet at http://www.fda.gov/cdrh/panel (click on Upcoming CDRH Advisory Panel/Committee Meetings).
ProcedureInterested 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 on or before October 30, 2006. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations and for approximately 30 minutes near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person 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 on or before October 30, 2006.
 Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
ConductFDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings.
Related Documents
Agenda:Meeting on November 16, 2006PDF
Brief Summary:Meeting on November 16, 2006Text
Briefing:Meeting on November 16, 2006Text
Minutes:Meeting on November 16, 2006PDF
Notice of Meeting:Meeting on November 16, 2006Text
Questions:Meeting on November 16, 2006PDF
Roster:Meeting on November 16, 2006PDF
Slides:Meeting on November 16, 2006Text
Transcript:Meeting on November 16, 2006PDF
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
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