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Center | Date | Time | Location |
---|---|---|---|
CDRH | June 17, 2005 | 8:30 a.m. - 5:00 p.m. | Hilton Washington,
DC North |
Agenda:
The committee will hear a presentation on the FDA Critical Path Initiative and
a presentation by the Office of Surveillance and Biometrics in the Center for
Devices and Radiological Health outlining their responsibility for the review
of postmarket study design. The committee will also hear an update on the status
of recent devices brought before the committee. Subsequently, the committee
will discuss, make recommendations, and vote on a premarket approval application
for a selective head cooling system intended for use in infants 36 weeks of
gestation or older at risk for moderate to severe hypoxic-ischemic encephalopathy
(HIE) to prevent or reduce the severity of HIE.
Background material and meeting information will become available no later than one business day before the meeting (Simply scroll down to the appropriate committee heading).
Procedure:
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 June 3, 2005. Oral presentations from the public will be scheduled
for approximately 30 minutes at the beginning of committee deliberations and
for approximately 30 minutes near the end of the deliberations. Time allotted
for each presentation may be limited. Those desiring to make formal oral presentations
should notify the contact person before June 3, 2005, 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 at 240-276-0450, ext. 113, at least 7 days
in advance of the meeting.
Contact Person:
Janet L. Scudiero, Center for Devices and Radiological Health (HFZ-410), Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1184
Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this
meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512513.