Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

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 June 2, 2004, from 10 a.m. to 6 p.m. and June 3, 2004, from 8 a.m. to 5 p.m.

Location: Gaithersburg Marriott, Salons A, B, C, and D, 9751 Washingtonian Blvd., Gaithersburg, MD.

Contact Person: Janet L. Scudiero, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1184, ext. 176, 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.

Agenda: On June 2, 2004, the committee will discuss, make recommendations, and vote on a premarket approval application for an artificial lumbar disc intended for spinal arthroplasty in skeletally mature patients with degenerative disc disease at one level from L4-S1. On June 3, 2004, from 8 a.m. to 1 p.m., the committee will discuss, make recommendations, and vote on a reclassification petition for total and unicompartmental mobile bearing knee joint prostheses. Also on June 3, 2004, from 1 p.m. to 5 p.m., the committee will discuss and make recommendations on a draft guidance document for clinical performance data requirements for hip joint prostheses. The draft guidance document is available at http://www.fda.gov/ohrms/dockets/dailys/04/apr04/040504/03n-0561-c00001-vol2.pdf . Background information for the topics, including the agenda and questions for the committee, will be available to the public 1 business day before the meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html . Material for the June 2 session will be posted June 1, 2004. Material for the June 3 session will be posted June 2, 2004.

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 by May 18, 2004. On June 2, 2004, oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations and for approximately 30 minutes near the end of the deliberations. On June 3, 2004, oral presentations from the public will be scheduled between approximately 8:15 a.m. and 8:45 a.m. and 1:15 p.m. and 1:45 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 18, 2004, 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.

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 301-594-1283, ext. 113, at least 7 days in advance of the meeting.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).