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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeGeneral and Plastic Surgery Devices Panel
Date and TimeThe meeting was held on the following dates:
Aug 25, 2005 8:00 AM - 6:00 PM
Aug 26, 2005 8:00 AM - 6:00 PM
LocationHilton Washington DC North/Gaithersburg, Salons A, B and C
620 Perry Pkwy
Gaithersburg , MD
Contact InformationDavid Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512519. Please call the Information Line or access the Internet address of http://www.fda.gov/cdrh/panelmtg.html for up-to-date information on this meeting.
AgendaOn August 25, 2005, the committee will hear a presentation on the FDA Critical Path Initiative and 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. On August 25 and 26, 2005, the committee will discuss and make recommendations on the classification of 5 preamendments medical devices: bone wax, medical maggots, medicinal leeches, tissue expander, and wound dressing with a drug. Background information for this meeting, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the August 25 and 26 sessions will be posted on August 24, 2005.
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 11, 2005. On August 25, 2005, oral presentations from the public will be scheduled between approximately 10:15 a.m. and 10:45 a.m., approximately 1:45 p.m. and 2:15 p.m., and approximately 4:30 p.m. and 5:00 p.m. On August 26, 2005, oral presentations from the public will be scheduled between approximately 9:30 a.m. and 10 a.m., approximately 1 p.m. and 1:30 p.m., and approximately 3:45 p.m. and 4:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before 5 p.m. on August 11, 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: Text
Roster: Text
Transcript: 8/25/2005Text
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).