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U.S. Department of Health and Human Services

Advisory Committees

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March 5, 2010: The General Hospital and Personal Use Devices Panel Meeting Notice

The General Hospital and Personal Use Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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: General Hospital and Personal Use 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 March 5, 2010, from 8 a.m.
to 5 p.m.


Location: Hilton Washington DC North/Gaithersburg, Salons C, D and E,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Tracy Phillips, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–
443–0572 in the Washington, DC area), code 3014512520. Please call the
Information Line for up-to-date information on this meeting. A notice in the
Federal Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
agency’s Web site and call the appropriate advisory committee hot line/phone
line to learn about possible modifications before coming to the meeting.
Agenda: On March 5, 2010, the committee will discuss and make
recommendations regarding clinical risks and benefits of post-market actions
in response to insulin pump failures. Insulin pumps are intended for
continuous delivery of insulin at set and variable rates and as an aid in the
management of diabetes mellitus in persons requiring insulin.
FDA intends to make background material available to the public no later
than 2 business days before the meeting. If FDA is unable to post the
background material on its Web site prior to the meeting, the background
material will be made publicly available at the location of the advisory
committee meeting, and the background material will be posted on FDA’s Web
site after the meeting. Background material is available at http://www.fda.gov/
AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate
advisory committee link.


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 on or before February 22, 2010.
Oral presentations from the public will be scheduled immediately following
lunch. Those desiring to make formal oral presentations should notify the
contact person 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 on or before February 11, 2010. Time allotted for
each presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the scheduled
open public hearing session, FDA may conduct a lottery to determine the
speakers for the scheduled open public hearing session. The contact person
will notify interested persons regarding their request to speak by February 12,
2010.


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 301–796–5966 at least 7 days
in advance of the meeting.


FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct
during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act
(5 U.S.C. app. 2).
Dated: January 5, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.