[Federal Register
Volume 81, Number 44 (Monday, March 7, 2016)] [Notices] [Page 11815]
From the Federal
Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No:
2016-04927] [[Page 11815]]
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DEPARTMENT OF HEALTH
AND HUMAN SERVICES: Food and Drug Administration Orthopaedic and Rehabilitation
Devices Panel of the Medical [Docket No. FDA-2016-N-0001] | Devices Advisory
Committee; Notice of Meeting
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AGENCY: Food and Drug
Administration, HHS.
ACTION: Notice.
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:
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 Wednesday, April 20, 2016, from 8 a.m. to 6 p.m.
Location: Hilton
Washington, DC/North, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel telephone number is 301-977-8900.
Contact Person: S.J.
Anderson, Center for Devices and Radiological Health, Food and Drug
Administration, Bldg. 66, rm. 1643, 10903 New Hampshire Ave., Silver Spring, MD
20993, email: Sara.Anderson@fda.hhs.gov, 301 796-7047, 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 always be published quickly enough to provide timely notice.
Therefore, that impact a previously announced advisory committee meeting cannot
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: The Committee
will discuss, make recommendations, and vote on the premarket approval
application for the Cartiva Synthetic Synthetic Cartilage Implant (SCI) is an
organic polymer-based Cartilage Implant (SCI), sponsored by Cartiva, Inc. The
Cartiva for treatment of degenerative and post-traumatic arthritis in the first
biomaterial to mimic biologic cartilage. The device is to be indicated the
following clinical conditions: hallux valgus or hallux limitus, metatarsophalangeal
joint in the presence of good bone stock along with hallux rigidus, and an
unstable or painful metatarsophalangeal joint.
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 the advisory committee meeting, and the
background material will be background material will be made publicly available
at the location of available at
http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm posted
on FDA's Web site after the meeting. Background material is 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 between approximately 1 p.m. and 2 p.m. Those
individuals interested in April 13, 2016. Oral resentations from the public
will be scheduled arguments they wish to present, the names and addresses of
proposed making formal oral presentations should notify the contact person and submit
a brief statement of the general nature of the evidence or each presentation
may be limited. If the number of registrants participants, and an indication of
the approximate time requested to make their presentation on or before April 5,
2016. Time allotted for lottery to determine the speakers for the scheduled
open public hearing requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may conduct
a session. The contact person will notify interested persons regarding their
request to speak by April 6, 2016. 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 disabilities. If you require 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 29,
2016. |Jill Hartzler Warner, Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016-04927
Filed 3-4-16; 8:45 am] | BILLING CODE 4164-01-P
Published at GPO.GOV
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