|CDRH||September 28, 2012||8:00 a.m. - 6:00 p.m.|| |
Hilton Washington DC North/Gaithersburg
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
AGENCY: 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.
Contact Person: Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver Spring, MD 20993-0002, Natasha.Facey@fda.hhs.gov, 301-796-5290, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find out further information regarding FDA advisory committee information. 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 September 28, 2012, the committee will discuss, make recommendations and vote on information regarding the humanitarian device exemption (HDE) application for the Argus II Retinal Prosthesis System sponsored by Second Sight Medical Products, Inc. The proposed Indication for Use for the Argus II (as stated in the HDE) is as follows:
The Argus II System is indicated for use in patients with severe to profound retinitis pigmentosa who meet the following criteria:
• Adults, age 25 years or older.
• Bare light or no light perception in both eyes with Snellen acuity worse than 20/2100 or 2.1 logMAR. If the patient has no residual light perception, the retina must be able to respond to electrical stimulation as evidenced by an electrically evoked response.
• Previous history of useful form vision.
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/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/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 September 17, 2012. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on September 28, 2012. 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 September 7, 2012. 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 September 10, 2012.
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).
Dated: July 16, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
September 28, 2012: Meeting Materials FDA Generated
Meeting Agenda: Ophthalmic Devices Panel, September 28, 2012(PDF - 35KB) [ARCHIVED] Panel Roster(PDF - 13KB) [ARCHIVED] FDA Questions: Ophthalmic Devices Panel, September 28, 2012(PDF - 28KB) [ARCHIVED] FDA Executive Summary(PDF - 5.3MB) [ARCHIVED] 24- Hour Summary(PDF - 32KB) [ARCHIVED] Voting Questions(PDF - 16KB) [ARCHIVED] FDA Presentation: Beylin and Dahr(PDF - 688KB) [ARCHIVED] FDA Presentation: Lepri and Dahr(PDF - 1.5MB) [ARCHIVED] FDA Presentation: Response to Panel Inquiries(PDF - 132KB) [ARCHIVED] FDA Presentation: Questions for Panel Discussion(PDF - 51KB) [ARCHIVED] Transcript: Ophthalmic Devices Panel, September 28, 2012(PDF - 1.2MB) [ARCHIVED]
September 28, 2012: Meeting Materials Non-FDA Generated
Sponsor Executive Summary: Argus II Retinal Prosthesis System H110002, September 28, 2012(PDF - 2.1MB) [ARCHIVED] Product Insert(PDF - 346KB) [ARCHIVED] Patient Manual(PDF - 463KB) [ARCHIVED] Surgeon Manual(PDF - 7KB) [ARCHIVED] Device Fitting Manual(PDF - 7KB) [ARCHIVED] Vision Rehabilitation Guide(PDF - 7KB) [ARCHIVED] Clinical Trial Protocol(PDF - 748KB) [ARCHIVED] FLORA(PDF - 7KB) [ARCHIVED] VisQOL(PDF - 105KB) [ARCHIVED] Massof Activity Inventory(PDF - 647KB) [ARCHIVED] Clinical Investigation Report(PDF - 7KB) [ARCHIVED] Safety Tables(PDF - 7KB) [ARCHIVED] Presentation: Second Sight(PDF - 3.5MB) [ARCHIVED]