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Federal Register: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Meeting on November 18, 2010(2)

Mon, 08/16/2010 - 5:31am
U.S. Food & Drug Administration

[Federal Register: August 16, 2010 (Volume 75, Number 157)]

[Notices]

[Page 49940]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr16au10-80]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

General and Plastic Surgery 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: General and Plastic Surgery 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 November 18, 2010, from

8 a.m. to 6 p.m.

Location: Holiday Inn College Park, Grand Ballroom, 10000 Baltimore

Ave., College Park, MD.

Contact Person: Margaret McCabe-Janicki, Center for Devices and

Radiological Health, Food and Drug Administration, 10903 New Hampshire

Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993-0002, 301-796-7029,

or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-

0572 in the Washington, DC area), code 3014512519. 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 November 18, 2010, the committee will discuss, make

recommendations, and vote on information related to the premarket

approval application for MelaFind, sponsored by MELA Sciences. MelaFind

is a computer-controlled multi-spectral dermoscope that uses light,

wavelengths from 430 nanometers (nm) (blue) through 950 nm (near

infrared), to image the skin through a thin layer of liquid (alcohol or

oil), making lesion structures under the skin surface visible to the

observer. A complementary metal oxide semiconductor digital camera

inside the probe captures the images and then differentiates them among

pigmented skin lesions for melanoma risk using predefined software

statistical pattern recognition algorithms.

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

November 9, 2010. Oral presentations from the public will be scheduled

between approximately 1 p.m. and 2 p.m. 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 28, 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 November

2, 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,

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: August 11, 2010.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.

[FR Doc. 2010-20156 Filed 8-13-10; 8:45 am]

BILLING CODE 4160-01-S

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