PROGRESS ON FDA RESURFACING APPROVAL DELAYED

[Guest guest]

Hi to surface Hippies:

recently made reference to an upcoming meeting of the

Orthopaedic and Rehabilitation Devices Panel to review the

resurfacing device.. I have checked the FDA website and the planned

meetings for march have both been cancelled. The next planned

meeting is not until June 3rd and June 4th. No details are yet

listed. A portion of each meeting is public permitting comments

from anyone interested.

This meeting is part of the process to obtain the FDA PMA (Pre-

Market approval), which once obtained will negate all the insurance

company arguments about experimental/investigational. The FDA has

tried to complete the process in about 180 days. No official

information available ye but I will keep checking.

For those interested, I have pasted the information from the FDA

WEBSITE. IMPORTANT: THE PANEL MEMBERS ARE PROHIBITED BY LAW FROM

MAKING ANY STATEMENTS ABOUT THE INVESTIGATION OR ANYTHING UNTIL

AFTER FDA APPROVAL SO DON " T TRY TO CALL THEM

MICHAEL IN NC

_______________________________________________________________

FROM THE FDA:

Please note: As of October 1, 2002, FDA charges a fee for review of

Premarket Approvals (THIS IS A MESSAGE TO MANUFACTURERS)

Overview

Introduction

Premarket approval (PMA) is the FDA process of scientific and

regulatory review to evaluate the safety and effectiveness of Class

III medical devices. Class III devices are those that support or

sustain human life, are of substantial importance in preventing

impairment of human health, or which present a potential,

unreasonable risk of illness or injury. Due to the level of risk

associated with Class III devices, FDA has determined that general

and special controls alone are insufficient to assure the safety and

effectiveness of class III devices. Therefore, these devices require

a premarket approval (PMA) application under section 515 of the FD&C

Act in order to obtain marketing clearance. Please note that some

Class III preamendment devices may require a Class III 510(k).

See " Historical Background " below for additional information.

PMA is the most stringent type of device marketing application

required by FDA. The applicant must receive FDA approval of its PMA

application prior to marketing the device. PMA approval is based on

a determination by FDA that the PMA contains sufficient valid

scientific evidence to assure that the device is safe and effective

for its intended use(s). An approved PMA is, in effect, a private

license granting the applicant (or owner) permission to market the

device. The PMA owner, however, can authorize use of its data by

another.

The PMA applicant is usually the person who owns the rights, or

otherwise has authorized access, to the data and other information

to be submitted in support of FDA approval. This person may be an

individual, partnership, corporation, association, scientific or

academic establishment, government agency or organizational unit, or

other legal entity. The applicant is often the inventor/developer

and ultimately the manufacturer.

FDA regulations provide 180 days to review the PMA and make a

determination. In reality, the review time is normally longer.

Before approving or denying a PMA, the appropriate FDA advisory

committee may review the PMA at a public meeting and provide FDA

with the committee's recommendation on whether FDA should approve

the submission. After FDA notifies the applicant that the PMA has

been approved or denied, a notice is published on the Internet (1)

announcing the data on which the decision is based, and (2)

providing interested persons an opportunity to petition FDA within

30 days for reconsideration of the decision.

The regulation governing premarket approval is located in Title 21

Code of Federal Regulations (CFR) Part 814, Premarket Approval. A

class III device that fails to meet PMA requirements is considered

to be adulterated under section 501(f) of the FD&C Act and cannot be

marketed.

Orthopaedic and Rehabilitation Devices Panel Roster

Chairperson

J. Yaszemski, M.D., Ph.D. [WORD]

Expertise: Orthopedic Surgery

Term: 11/13/02 - 8/31/05

Senior Associate Consultant and Associate Professor

Dept. of Orthopedic Surgery

Mayo Clinic and Graduate School of Medicine

200 1st Street SW

Rochester, MN 55905 Executive Secretary

Janet Scudiero, Acting

Center for Devices and Radiological Health

Office of Device Evaluation/DGRND

9200 Corporate Blvd. HFZ-410

Rockville, MD 20850

jls@...

X 176

Maureen A. Finnegan, M.D. [WORD]

Expertise: Orthopedic Surgery

Term: 10/11/00 - 8/31/04

Associate Professor

Dept. of Orthopaedic Surgery

Univ. of Texas Southwestern Med Center

5323 Harry Hines Blvd.

Dallas, TX 75390-8883

J. Friedman, M.D. [WORD]

Expertise: Orthopedic Surgery

Term: 11/13/02 - 8/31/06

Clinical Professor of Orthopaedic Surgery

Medical University of South Carolina

2270 Crossing Dr. Suite 110

ton, SC 29414

S. Kirkpatrick, M.D. [WORD]

Expertise: Orthopedic Implants

Term: 11/13/02 - 8/31/06

Associate Professor

Dept. of Surgery, Div. of Orthopaedic Surgery

Univ. of Alabama School of Medicine Faculty

510 20th St South FOT-Suite 940

Birmingham, AL 35294-3295

Kinley Larntz, Ph.D. [WORD]

Expertise: Biostatistics

Term: 11/13/02 - 8/31/05

Professor Emeritus

Dept. of Applied Statistics

University of Minnesota

6339 East Greenway, #102-172

sdale, AZ 85254-6517 Li, Ph.D. [WORD]

Expertise: Biomaterials; Materials Science

Term: 10/11/00 - 8/31/04

President

Medical Device Testing and Innovations

1469 Tallevast Road

Sarasota, FL 34243

**Sally Maher, ESQ. [WORD]

Expertise: Bacteriology

Term: 12/31/00 - 8/31/04

Senior Director, Regulatory Affairs

Clinical Research

& Nephew Endoscopy

150 Minuteman Road

Andover, MA 01810

Sanjiv H. Naidu, M.D., Ph.D. [WORD]

Expertise: Orthopedic Surgery

Term: 11/13/02 - 8/31/06

Associate Professor of Orthopaedic Surgery

Dept. of Orthopaedics and Rehabilitation

Pennsylvania State Univ., Hershey Medical Ctr

500 University Dr.

Hershey, PA 17033

**Industry Representative

Panel/Committee Name Date Meeting NO DETAILS YET

Ortho. & Rehabilitation Devices Panel Mar 22, 2004 canceled

Ortho. and Rehabilitation Devices Panel Mar 23, 2004 canceled

Ortho. and Rehabilitation Devices Panel Jun 3, 2004 PROPOSED

Ortho. and Rehabilitation Devices Panel Jun 4, 2004 PROPOSED

Ortho. and Rehabilitation Devices Panel Aug 12, 2004 PROPOSED

Ortho. and Rehabilitation Devices Panel Aug 13, 2004 PROPOSED

Ortho. and Rehabilitation Devices Panel Dec 2, 2004 PROPOSED

Ortho. and Rehabilitation Devices Panel Dec 3, 2004 PROPOSED