• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive

  • Print
  • Share
  • E-mail
-
New SearchBack To Search Results
Name of CommitteeOphthalmic Devices Panel
Date and TimeThe meeting was held on the following dates:
Jan 17, 02 9:30 AM - 5:00 PM
Jan 18, 02 8:30 AM - 3:30 PM
LocationHilton Washington DC North/Gaithersburg, Salons A, B and C
620 Perry Parkway
Gaithersburg , MD
Contact InformationSara M. Thornton, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2053, SMT@CDRH.FDA.GOV, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12396. Please call the Information Line for up-to-date information on this meeting. (E-mail contact SMT@CDRH.FDA.GOV)
AgendaOn January 17, 2002, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) on an endocapsular tension ring for the stabilization of the lens capsular bag. On January 18, 2002, the committee will discuss, make recommendations, and vote on a PMA on an orthokeratology contact lens for corneal refractive therapy with overnight wear for the temporary reduction of myopia. Background information for each day’s 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. Material for the January 17 session will be posted on January 16, 2002; material for the January 18 session will be posted on January 17, 2002.
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 January 7, 2002. On January 17, 2002, formal oral presentations from the public will be scheduled between approximately 9:45 a.m. and 10:15 a.m., and on January 18, 2002, between approximately 8:45 and 9:15 a.m. Near the end of the committee deliberations on each PMA, a 30-minute open public session will be conducted for interested persons to address issues specific to the submission before the committee. Those desiring to make formal oral presentations should notify the contact person before January 7, 2002, 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.
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 for January 17, 2002)Text
Agenda: (Draft for January 18, 2002)Text
Briefing: Text
Minutes: Text
Questions: (For January 17, 2002 Meeting)Text
Questions: (For January 18, 2002 Meeting)Text
Roster: Word
Summary: Text
Transcript: (for 1/17/02)Rich Text Format
Transcript: (for 1/18/02)Rich Text Format
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
-
-