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Center | Date | Time | Location |
---|---|---|---|
CDRH | October 6, 2004 | 8 a.m. - 5:30 p.m. | Hilton Washington
DC North |
Agenda:
The 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 followup 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 labeling. The discussion will not include continuous positive airway
pressure (CPAP) devices and surgical treatments for OSA.
Background material and meeting information will become available no later than one business day before the meeting (Simply select the appropriate committee link).
Closed Committee Deliberations:
On 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)).
Procedure:
On October 6, 2004, from 8:30 a.m. to 5:30 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 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.
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, Conference Management Staff, at 301–594–1283,
ext. 113, at least 7 days in advance of the meeting.
Contact Person:
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 3014512522. Please call the Information Line
for up-to-date information on this meeting.