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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeOrthopaedic and Rehabilitation Devices Panel
Date and TimeThe meeting was held on the following dates:
Jun 2, 2006 8:30 AM - 3:30 PM
LocationHoliday Inn, Walker/Whetstone Rooms
Two Montgomery Village Ave.
Gaithersburg , MD
Contact InformationJanet L. Scudiero, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512521. Please call the Information Line for up-to-date information on this meeting.
AgendaThe committee will discuss and make a recommendation on the reclassification of the non-invasive bone growth stimulator indicated for the treatment of established nonunion fractures acquired secondary to trauma and as an adjunct to the treatment of lumbar spinal fusion surgery for one or two levels. Background information for the topics, 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/panel (click on Upcoming CDRH Advisory Panel/Committee Meetings).
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 May 19, 2006. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of the committee deliberations and for approximately 30 minutes near the end of the deliberations. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 19, 2006, 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:Draft Agenda (PDF)PDF
Briefing:Briefing InformationText
Minutes:June 2, 2006 MeetingPDF
Other:Nature and Basis Statements of Conflict(s) of InterestText
Questions:Final Questions for June 2, 2006 MeetingPDF
Roster:Roster (PDF)PDF
Summary: Text
Transcript: PDF
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).