[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Notices]
[Pages 66550-66551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32024]
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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). At least one
portion of the meeting will be closed 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
[[Page 66551]]
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on December 18, 1998, 10:15
a.m. to 5:30 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: Michael G. Bazaral, Center for Devices and
Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8609, ext. 140, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 12624. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The committee will discuss and make recommendations on
general issues related to the classification of tracheal gas
insufflation (TGI) devices used to provide part or all of the breathing
gas for treatment of respiratory failure or respiratory insufficiency.
The use of the TGI catheter, tube or lumen only for supply of fresh gas
distinguishes TGI from common tracheal tubes and tracheostomy tubes, in
which the gas flow alternates between inhalation and exhalation. The
draft versions of five questions FDA will ask the committee to address
are listed as follows:
1. For the evaluation of effectiveness of specific TGI systems as
an adjunct to ventilation of adults, is reduction of minute ventilation
(or PCO2) without appreciable increase in end-expiratory
lung volume or pressure a sufficient endpoint? Is this the correct
endpoint?
2. For ventilation of adults, is there now sufficient understanding
of TGI to be reasonably sure that TGI, with adequate monitoring and
other understood safety provisions, will not have worse outcomes? Or
does TGI raise concerns that will require that FDA review data on
patient outcomes?
3. Are there special considerations about the data FDA should
review for TGI submissions in relation to ventilation of children,
infants, newborns, or premature infants?
4. What are the minimum system functions that include all the
functions needed to provide TGI for clinical use as an adjunct to or
replacement for conventional ventilation?
5. What specific safety provisions are important? Is distal
pressure monitoring essential?
Procedure: On December 18, 1998, from 12:15 p.m. to 5:30 p.m., the
meeting is open to the public. Interested persons may present
information or views, orally or in writing, on issues pending before
the committee. Written submissions must be made to the contact person
by December 11, 1998. Oral presentations from the public will be
scheduled between approximately 12:30 p.m. and 1 p.m., and between
approximately 4 p.m. and 4:30 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person before December 11, 1998, and submit a brief
statement of the general nature of the arguments they wish to present,
the names and addresses of the proposed participants, and an indication
of the approximate time requested to make their presentation.
Closed Committee Deliberations: On December 18, 1998, from 10:15
a.m. to 12:15 p.m., the meeting will be closed to permit FDA to present
trade secret and/or confidential commercial information (5 U.S.C.
522b(c)(4)) regarding pending issues and applications.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 24, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-32024 Filed 12-1-98; 8:45 am]
BILLING CODE 4160-01-F
