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U.S. Department of Health and Human Services

Advisory Committees

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October 22 -23, 2009: Hematology and Pathology Devices Advisory Committee Meeting Announcement

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: Hematology and Pathology 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 October 22 and 23, 2009,
from 8 a.m. to 5 p.m.
 
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
 
Contact Person: Louise E. Magruder, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301-796-6175, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512515. 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 October 22 and 23, 2009, the committee will discuss and
make recommendations on public health issues related to the use of
digital whole slide imaging systems to replace conventional light
microscopy for diagnostic surgical pathology. In the scope of this
meeting, digital pathology is defined as converting what can be
observed by conventional light microscopy on histologic glass slides
into digital whole slide images via digital scanners; viewing these
images via a computer monitor to render pathologic diagnosis of the
lesion of interest; and digitally archiving and retrieving these
images. The committee will not be discussing computer-assisted image
analysis or remote real-time microscopy.
 
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 on the FDA Internet under the appropriate date at http://
www.fda.gov/AdvisoryCommittees/Calendar/default.com. 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
October 15, 2009. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. each day. 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 October 1, 2009. 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 October
8, 2009.
 
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, 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).