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| Name of Committee | Microbiology Devices Panel |
| Date and Time | The meeting was held on the following dates:
Dec 13, 02 9:30 AM - 4:00 PM
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| Location | Hilton Washington DC North/Gaithersburg, Salons A and B
620 Perry Parkway
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 |
| Agenda | The committee will discuss, make recommendations, and vote on a premarket approval application for the quantitation of human hepatitis C viral RNA in serum or plasma of HCV-infected individuals. The test is indicated for use as an aid in the management of HCV-infected individuals to predict response to HCV therapy. Background information, 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 will be posted on December 12, 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 December 7, 2002. On December 13, 2002, oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of the PMA discussion and for approximately 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 December 7, 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. |
| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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