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U.S. Department of Health and Human Services

Advisory Committees

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January 27-28, 2011, Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement

 


IMPORTANT NOTICE: The start time for January 27th will be delayed until 9:00 a.m. due to weather.

 

Center Date Time Location
CDRH January 27- 28, 2011 8:00 a.m. - 6:00 p.m.

Hilton, Washington DC North/Gaithersburg
620 Perry Parkway
Gaithersburg, MD 

 

 

 
FDA is opening a docket for public comment on this meeting. The docket number is FDA-2010-N-0585. The docket will open for public comment on November 26, 2010. The docket will close on January 25, 2011. Interested persons may submit electronic or written comments regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit a single copy of electronic comments or a paper copy of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this meeting notice. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
 
Agenda
On January 27 and 28, 2011, the committee will discuss and make recommendations regarding the possible reclassification of devices indicated for use in electroconvulsive therapy.
 
Meeting Materials
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
 2011 Meeting Materials, Neurological Devices Panel          
 
Public Participation and Sponsor Information
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 January 14, 2011. 
 
Oral presentations from the public will be scheduled at approximately 10 a.m., immediately following the FDA’s presentation, on January 27, 2011. 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 6, 2011. 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 7, 2011.
 
Contact Information:
James Engles
Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Ave.
Silver Spring, MD 20993
 
FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington, DC area)
Code: 3014512513
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 Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

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.

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 Martha Monser at (301) 796-4627 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 for procedures on public conduct during advisory committee meetings2

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

 
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