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||Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee.|
|General Function of the Committee||To provide advice and recommendations to the agency on FDA's regulatory issues.|
|Date and Time||The meeting will be held on July 17, 2009, from 8 a.m. to 5 p.m.|
Hilton Washington DC North/Gaithersburg,
Salons A, B, and C,
620 Perry Pkwy.,
Louise E. Magruder,
Center for Devices and Radiological Health (HFZ-440),
Food and Drug Administration,
2098 Gaither Rd., Rockville, MD 20850,
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512515.
Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
The committee will discuss and make recommendations on a (Clinical Laboratory Improvement Amendment) Waiver application for the HemoCue WBC Analyzer, sponsored by HemoCue, Inc. The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) counts in capillary or venous whole blood and can be used in clinical laboratories and at point-of-care settings.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.
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 on or before July 2, 2009. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 9:15 a.m. 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 June 24, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 25, 2009.
Materials for this meeting: 2009 Meeting Materials for the Hematology and Pathology Devices Panel Meeting