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General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee

Agenda:
The committee will hear a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of post market study design. The committee will discuss and make recommendations on methods to assess the potential of disease transmission by multiple-use nozzle jet injectors (i.e., jet injectors for which the fluid path for the injection is used more than once). The discussion will include premarket testing recommendations to address this issue

Background material and meeting information will become available no later than one business day before the meeting (Simply scroll down to the appropriate committee heading).

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 August 3, 2005. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of deliberations and for approximately 30 minutes near the end of deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 3, 2005, 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.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 240-276-0450, ext. 113, at least 7 days in advance of the meeting.

Contact Person:
Scott A. Colburn, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-827-6892.

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512520.