Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CDRH Advisory Meeting Materials Archive
  • Print
  • Share
  • E-mail
-
New SearchBack To Search Results
Name of CommitteeEar, Nose, and Throat Devices Panel
Date and TimeThe meeting was held on the following dates:
Oct 6, 2004 8:00 AM - 5:00 PM
LocationHilton Washington DC North/Gaithersburg, Salons A, B, and C
620 Perry Parkway
Gaithersburg , MD
Contact InformationSara 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 3014512522. Please call the Information Line for up-to-date information on this meeting.
AgendaThe committee will discuss general issues surrounding the prescription use versus over the counter (OTC) use of devices intended to treat snoring or mild to severe obstructive sleep apnea (OSA). The discussion will include the role of the medical/dental provider in the diagnosis, treatment and follow-up of snoring and OSA; the ability of the patient to self diagnose and treat OSA; the types of clinical data that would be needed to support an OTC intended use; and the components of adequate device labelling. The discussion will not include continuous positive airway pressure (CPAP) devices and surgical treatments for OSA. Background information, including the attendee list, agenda, and questions for the committee, will be available to the public one business day before the meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html.
ProcedureOn October 6, 2004, from 8:30 a.m. to 5:30 p.m., the meeting will be 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 September 17, 2004. Oral presentations from the public will be scheduled between approximately 9:15 a.m. and 9:45 a.m. Near the end of the committee discussion a second 30-minute open public session will be conducted for interested persons to comment further on the discussion topic. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 17, 2004 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.
Closed Committee InformationOn October 6, 2004, from 8 a.m. to 8:30 a.m., the meeting will be closed to permit FDA staff to present to the committee trade secret and/or confidential commercial information relevant to pending and future device submissions for ear, nose and throat devices. This portion of the meeting will be closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).
 Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.
ConductFDA 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
Agenda: Text
Brief Summary: Text
Briefing: Text
Questions: (Final)Text
Roster: Text
Roster: Text
Slides: Text
Summary: Text
Transcript: Text
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
-
-