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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeGeneral Hospital and Personal Use Devices Panel
Date and TimeThe meeting was held on the following dates:
Aug 9, 2005 8:00 AM - 4:00 PM
LocationHilton Washington DC North/Gaithersburg,Salons A, B and C
620 Perry Parkway
Gaithersburg , MD
Contact InformationScott A. Colburn, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD, 20850, 301-827-6892, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512520. Please call the Information Line for up-to-date information on this meeting.
AgendaThe 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 postmarket 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 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/panelmtg.html.
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 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.
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: Text
Brief Summary: Text
Briefing: Text
Questions: PDF
Roster: (Panel)Text
Roster: (Speaker)Text
Transcript: Text
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).