|CDRH||February 10, 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-2011-N-0002]
Neurological 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: Neurological 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: Avena Russell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring MD 20993-0002, Avena.Russell@fda.hhs.gov, 301-796-3805, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area. 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.
Agenda: On February 10, 2012, the committee will discuss and make recommendations regarding the possible reclassification of cranial electrotherapy stimulator (CES) devices. On August 8, 2011 (76 FR 48062), FDA issued a proposed rule which, if made final, would make CES devices Class III requiring premarket approval. In response to the proposed rule, FDA received petitions under section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)(2)(B)) requesting a change in classification. The reclassification petitions are available for public review and comment at www.regulations.gov under docket number FDA-2011-N-0504. The committee discussion will include the existing data to support CES safety and effectiveness and whether the data are sufficient to develop special controls to support regulation of these devices under Class II.
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/Calendar/default.htm. Scroll down to the appropriate advisory committee 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 6, 2012. Oral presentations from the public will be scheduled between approximately 10 a.m. and 11 a.m. 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 27, 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 January 30, 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 James Clark at James.Clark@fda.hhs.gov or 301-796-5293, 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: November 9, 2011.
Acting Assistant Commissioner for Policy.
February 10, 2012: Meeting Materials FDA Generated
Meeting Agenda(PDF - 35KB) [ARCHIVED] Panel Roster.(PDF - 8KB) [ARCHIVED] Pascual-Leone Waiver: Alvaro Pascual-Leone, M.D., Ph.D. was unable to attend this meeting(PDF - 86KB) [ARCHIVED] Pascual-Leone Acknowledgment(PDF - 39KB) [ARCHIVED] Panel Questions(PDF - 50KB) [ARCHIVED] FDA Executive Summary(PDF - 637KB) [ARCHIVED] FR Notice - Proposed Rules(PDF - 351KB) [ARCHIVED] Regulatory Reference Sheet(PDF - 17KB) [ARCHIVED] Presentation: Device Reclassification Intro(PDF - 147KB) [ARCHIVED] Presentation: Regulatory Background(PDF - 354KB) [ARCHIVED] Presentation: FDA(PDF - 354KB) [ARCHIVED] Presentation: FDA Back-up Slides(PDF - 207KB) [ARCHIVED] Summary of the Neurological Devices Panel Meeting: February 10, 2012(PDF - 109KB) [ARCHIVED] Transcript(PDF - 1.1MB) [ARCHIVED] Transcript: Addendum(PDF - 54KB) [ARCHIVED]
February 10, 2012: Meeting Materials Non-FDA Generated
Petition: Electromedical Products International, Inc.(PDF - 12.7MB) [ARCHIVED] Petition: Fisher Wallace Laboratories, LLC(PDF - 1.7MB) [ARCHIVED] Petition: Neuro-Fitness(PDF - 2.3MB) [ARCHIVED] Presentation: Electromedical Products International, Inc.(PDF - 1.1MB) [ARCHIVED] Presentation: Fisher Wallace Laboratories, LLC(PDF - 666KB) [ARCHIVED] Presentation: Neuro-Fitness(PDF - 1.3MB) [ARCHIVED]