Document ID: FDA-2009-N-0664-0084
Agency: fda
Document Type: Notice
Title: Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2009-09-10T04:00Z

[Federal Register: September 10, 2009 (Volume 74, Number 174)]
[Notices]               
[Page 46609-46610]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se09-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Hematology and Pathology 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: 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

[[Page 46610]]

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).

    Dated: September 4, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21810 Filed 9-9-09; 8:45 am]

BILLING CODE 4160-01-S