Wednesday, March 16, 2016

News: Meeting to discuss the Cartiva Synthetic Cartilage Implant (SCI) is an organic polymer-based biomaterial to mimic biologic cartilage.

[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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