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| Center | Date | Time | Location |
|---|---|---|---|
| CDRH | June 9, 2003 June 10, 2003 |
12:30 p.m. - 5:00
p.m. 8:30 a.m. - 4:30 p.m. |
Hilton DC North
- Gaithersburg |
Agenda:
On June 9, 2003, the committee will hear a presentation on post-approval studies
and adverse events related to an intrapartum fetal pulse oximeter.
On June 10, 2003, the committee will discuss, make recommendations, and vote
on a premarket approval application for an endometrial ablation device.
Background information, including the 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/panel/index.html.
Material for the June 9th session will be posted on June 6, 2003; material for
the June 10th session will be posted on June 9, 2003.
Closed Committee Deliberations:
On June 9, 2003, from 12:30 p.m. to 2:30 p.m., the meeting will be closed to
permit discussion and review of trade secret and/or confidential information
(5 U.S.C. 552b(c)(4)) presented by the sponsor.
Procedure:
On June 9, 2003, from 2:30 p.m. to 5:00 p.m., and on June 10, 2003, from 8:30
a.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 May 30, 2003. Oral presentations from the public will be scheduled between
approximately 3:00 p.m. and 4:00 p.m. on June 9, 2003, and between 8:45 a.m.
and 9:15 a.m. and between approximately 3:00 p.m. and 3:30 p.m. on June 10,
2003. Time allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person before May 30,
2003, 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:
Joyce M. Whang, Center for Devices and Radiological Health (HFZ-470), Food and
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180
, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12524. Please call the Information Line for up-to-date
information on this meeting.