|
|
| Name of Committee | Ear, Nose, and Throat Devices Panel |
| Date and Time | The meeting was held on the following dates:
Aug 16, 02 10:30 AM - 4:30 PM
|
| Location | Holiday Inn, Walker/Whetstone Rooms
Two Montgomery Village Ave
Gaithersburg
, MD |
| Contact Information | Sara M. Thornton, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2053, ext. 127, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12522. Please call the Information Line for up-to-date information on this meeting. |
| Agenda | The committee will discuss and make recommendations on a draft guidance entitled “Implantable Middle Ear Hearing Device; Draft Guidance for Industry and FDA.” The topics for discussion will include the appropriate study population, objective measurement techniques for comparison of acoustic hearing aids and middle ear hearing devices, and subjective questionnaire development for determining postoperative effectiveness and quality of life outcome measures. The draft guidance is available to the public on the Internet at http://www.fda.gov/cdrh/ode/guidance/1406.html. Background information, including the attendee list, agenda, and questions for the committee, will be available to the public on August 15, 2002, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. |
| Procedure | On August 16, 2002, from 12:30 p.m. to 4:30 p.m., the meeting is open to the public. 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 by August 8, 2002. Oral presentations from the public will be scheduled between approximately 12:40 p.m. and 1:10 p.m. and between approximately 3:45 p.m. and 4:15 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before August 8, 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. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. |
| Closed Committee Information | On August 16, 2002, from 10:30 a.m. to 12:30 p.m., the meeting will be closed to the public to permit discussion and review of trade secret and/or confidential information regarding pending issues and applications (5 U.S.C. 552b(c)(4)). |
| Conduct | FDA 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 | |
| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
|
