Document ID: FDA-2010-N-0001-0016
Agency: fda
Document Type: Notice
Title: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2010-03-02T05:00Z

[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Notices]
[Pages 9422-9423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4260]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Orthopaedic and Rehabilitation 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

[[Page 9423]]

(FDA). The meeting will be open to the public.
    Name of Committee: Orthopaedic and Rehabilitation 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 23, 2010, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C 
and D, 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, 301-796-6150, Tracy.Phillips@fda.hhs.gov, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512521. 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 23, 2010, the committee will discuss and make 
recommendations on issues relevant to FDA's reevaluation of the ReGen 
Collagen Scaffold (CS) device (marketed as the Menaflex[reg]), which 
FDA cleared in K082079 on December 18, 2008, sponsored by ReGen 
Biologics, Inc. The indications for use statement for this device 
states that the device is intended for use in surgical procedures for 
the reinforcement and repair of soft tissue injuries of the medial 
meniscus. In repairing and reinforcing medial meniscal defects, the 
patient must have an intact meniscal rim and anterior and posterior 
horns for attachment of the mesh. In addition, the surgically prepared 
site for the CS must extend at least into the red/white zone of the 
meniscus to provide sufficient vascularization. The CS reinforces soft 
tissue and provides a resorbable scaffold that is replaced by the 
patient's own soft tissue. The CS is not a prosthetic device and is not 
intended to replace normal body structure.
    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 views, orally or in 
writing, on issues pending before the committee. These views may be 
submitted in writing to the contact person on or before March 16, 2010. 
Oral presentations from the public will be scheduled at approximately 1 
p.m., 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 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 
March 8, 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 March 9, 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: February 24, 2010.
Joanne Less,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-4260 Filed 3-1-10; 8:45 am]
BILLING CODE 4160-01-S