[Federal Register: April 21, 2005 (Volume 70, Number 76)]
[Notices]
[Page 20757-20758]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ap05-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Anesthesiology and Respiratory Therapy Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Anesthesiology and Respiratory Therapy Devices
Panel of the Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on May 13, 2005, from 8
a.m. to 5:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A and B,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Neel Patel, Center for Devices and Radiological
Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-443-8611, ext. 3, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512624. Please call the Information Line for up-to-date
information on this meeting.
Agenda: The committee will hear a presentation on FDA's Critical
Path Initiative and a presentation by the Office of Surveillance and
Biometrics in
[[Page 20758]]
the Center for Devices and Radiological Health outlining their
responsibility for the review of postmarket study design. The committee
will also discuss and make recommendations regarding general issues for
pulse oximeters. The issues include the equivalence of reflectance
sensor technology to transmissive sensor technology; validation
recommendations for neonatal intended use; and over-the-counter (OTC)
use of pulse oximeters.
Background information for the topics, including the agenda and
questions for the committee, will be available to the public 1 business
day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html
.
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 May 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 by May 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 Shirley Meeks,
Conference Management Staff, at 240-276-0450, ext. 105, at least 7 days
in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 13, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-7948 Filed 4-20-05; 8:45 am]
BILLING CODE 4160-01-S