This PDF is the current document as it appeared on Public Inspection on 12/23/2013 at 08:45 am.
Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on February 14, 2014, from 8 a.m. to 6 p.m.
Location: Gaithersburg Marriott Washingtonian Center, Salons A, B, C and D, 9751 Washingtonian Blvd., Gaithersburg, MD 20878.
Contact Person: James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1609, Silver Spring, MD 20993, James.Swink@fda.hhs.gov, 301-796-6313, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
Agenda: On February 14, 2014, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Visian Toric Implantable Collamer Lens (TICL) sponsored by STAAR Surgical Company. “Visian TICL proposed indications for use:
- For adults 21-45 years of age;
- For correction of myopic astigmatism in adults with spherical equivalent ranging from −3.0D to ≤−15.0D with cylinder of 1.0D to 4.0D;
- For the reduction of myopic astigmatism in adults with spherical equivalent ranging from greater than −15.0D to −20.0D with cylinder 1.0D to 4.0D;
- With an anterior chamber depth (ACD) of 3.0 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 Diopter for 1 year prior to implantation); and
- The Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.”
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 Start Printed Page 77689be 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/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.
Procedure: Interested 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 February 7, 2014. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on February 14, 2014. Those individuals interested in making 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 January 30, 2014. 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 February 3, 2014.
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams at Annmarie.Williams@fda.hhs.gov or 301-796-5966, at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).Start Signature
Dated: December 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-30579 Filed 12-23-13; 8:45 am]
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