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U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

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Name of CommitteeOphthalmic Devices Panel
Date and TimeThe meeting was held on the following dates:
Jun 10, 2008 8:00 AM - 4:30 PM
LocationHilton Washington DC North/Gaithersburg, Salons A, B and C
620 Perry Parkway
Gaithersburg , MD
Contact InformationKaren F. Warburton, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, (240) 276-4238, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512396. 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.
AgendaThe committee will discuss general issues concerning the postmarket experience with various contact lens care products. The discussion will include recommendations on contact lens care product development topics such as preclinical testing and clinical performance measures, and labeling for contact lenses and lens care products. 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. Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link.
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 on or before June 5, 2008. Oral presentations from the public will be scheduled on June 10, 2008, between approximately 9:30 a.m. and 10 a.m., and between approximately 3:30 p.m. and 4 p.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 May 28, 2008. 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 May 29, 2008.
 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 for June 10, 2000 MeetingPDF
Agenda:Final Agenda for June 10, 2008 MeetingPDF
Brief Summary:Brief Summary for June 10, 2000 Meeting Text
Briefing:Briefing Information for June 10, 2000 Meeting Text
Minutes:Minutes for June 10, 2008 Meeting PDF
Other:Written Comments for June 10, 2000 MeetingText
Other:Waivers for Conflicts of Interest for June 10, 2008 Meeting Text
Questions:Draft Questions for June 10, 2000 Meeting Text
Roster:Draft Roster for June 10, 2000 MeetingPDF
Slides:Slides for June 10, 2008 MeetingText
Transcript:Transcript for June 10, 2008 MeetingPDF
Transcript:Transcript for June 10, 2008 MeetingPDF
Transcript:Transcript for June 10, 2008 MeetingPDF
Transcript:Transcript for June 10, 2008 MeetingPDF
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).