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| Name of Committee | Microbiology Devices Panel |
| Date and Time | The meeting was held on the following dates:
Mar 7, 2002 10:30 AM - 3:00 PM
Mar 8, 2002 8:30 AM - 3:30 PM
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| Location | Gaithersburg Holiday Inn, Walker/Whetstone Rooms
Two Montgomery Village Ave.
Gaithersburg
, MD |
| Contact Information | Freddie M. Poole, Center for Devices and Radiological Health, (HFZ-440), Food and Drug Administration, 2098 Gaither Road, Rockville, MD 20850, 301-594-2096 ext. 111, 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 | On March 7, 2002, the committee will discuss and make recommendations on the classification of preamendments in vitro diagnostic products to identify Bacillus anthracis and Yersinia pestis. No applications will be reviewed at this meeting. On March 8, 2002, the committee will discuss, make recommendations, and vote on a supplement to a premarket approval application for a nucleic acid hybridization in vitro diagnostic device for the detection of thirteen high-risk types of human papillomavirus (HPV) DNA in cervical specimens. The test is indicated for use as a general population screening test in conjunction with the Papanicolaou smear for women 30 years of age and older, as an aid to determine the absence of high-grade cervical disease or cancer. The test is not intended for use as a screening test in the general population for women under 30 years of age. Background information for each day’s 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/panelmtg.html. Material for the March 7 session will be posted on March 6, 2002; material for the March 8 session will be posted on March 7, 2002. |
| 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 March 4, 2002. On March 7, 2002, formal oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:15 p.m., and between approximately 2:30 p.m. and 2:45 p.m. On March 8, 2002, formal oral presentations from the public will be scheduled between approximately 11 a.m. and 11:45 a.m., and between approximately 3 p.m. and 3:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 4, 2002, 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. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. |
| Conduct | FDA 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 | |
| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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