Document ID: FDA-2013-N-0001-0048
Agency: fda
Document Type: Notice
Title: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2013-05-23T04:00Z

[Federal Register Volume 78, Number 100 (Thursday, May 23, 2013)]
[Notices]
[Pages 30928-30929]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12230]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-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 June 26, 2013, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom 2, Montgomery Village Ave., 
Gaithersburg, MD 20879. The hotel phone number is 301-948-8900.
    Contact Person: Avena Russell, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 1535, Silver Spring, MD 20993-0002, Avena.Russell@fda.hhs.gov, 
301-796-3805, or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm 
and scroll down to the appropriate advisory committee meeting link, or 
call the advisory committee information line to learn about possible 
modifications before coming to the meeting.
    Agenda: On June 26, 2013, the committee will discuss and make 
recommendations regarding the possible reclassification of blood lancet 
devices. The committee will discuss whether new scientific data are 
sufficient to support the reasonable assurance of safety and 
effectiveness to develop special controls that support regulation of 
blood lancets from class I to class II and class III. The four subsets 
of blood lancets have been identified with the following indications 
for use:
     Blood lancet with an integral sharps injury prevention 
feature is for single use only, disposable blood lancet with a blade 
attached to a solid base which includes an integral sharps injury 
prevention feature that allows the device to be used once and then 
renders it inoperable and incapable of further use and which is used to 
puncture the skin to obtain a drop of blood for diagnostic purposes;
     Blood lancet without an integral sharps injury prevention 
feature is for single use only, disposable blood lancet with a blade 
attached to a solid base which is used to puncture the skin to obtain a 
drop of blood for diagnostic purposes;
     Blood lancet for single patient use only is a multiple use 
capable blood lancet with a single use blade inserted into a solid, 
reusable base which is used only for a single patient to puncture the 
skin to obtain a drop of blood for diagnostic purposes; and
     Multiple use blood lancet for multiple patient use is a 
multiple use capable blood lancet with a single use blade inserted into 
a solid, reusable base which is used for multiple patients to puncture 
the skin to obtain a drop of blood for diagnostic purposes.
    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 meeting 
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 June 
7, 2013. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Those individuals interested in making 
formal oral

[[Page 30929]]

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 June 6, 2013. 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 June 10, 
2013.
    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, 
Committee Management Staff, at 301-796-5966 or 
AnnMarie.Williams@fda.hhs.gov 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: May 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-12230 Filed 5-22-13; 8:45 am]
BILLING CODE 4160-01-P