THE MEDICAL DEVICE ADVISORY COMMITTEE

MEETING OF THE

DENTAL PRODUCTS PANEL

 

 

 

 

 

Holiday Inn Gaithersburg

Walker/Whetstone Salons

Gaithersburg, Maryland

Thursday, May 22, 2003

 

DRAFT MEETING AGENDA

DENTAL PRODUCTS PANEL

Holiday Inn Gaithersburg

Walker/Whetstone Salons

Gaithersburg, MD

Thursday, May 22, 2003

 

9:30 a.m.                      CALL TO ORDER

9:30 – 9:45 a.m.           OPEN SESSION -- Welcome and Introductory Remarks

·        Michael E. Adjodha, Executive Secretary

·        Dr. Leslie B. Heffez, Chairman

9:45 - 10:15 a.m.          FDA Presentation – Reclassification of Tricalcium Phosphate Granules for Dental Bone Repair (21 CFR 872.3930)

·        Dr. Kevin P. Mulry, Acting Chief, Dental Devices Branch, DAGID

·        Dr. Robert S. Betz, Lead Reviewer, Dental Devices Branch

10:15 - 11:15 a.m.        Sponsor Presentation – Petition to Reclassify 21 CFR 872.3930

·        Dr. Vincent J. Morgan – The Petitioner

·        Mr. Thomas Driskell – Inventor

·        Dr. John R. Long – Chemist

11:15 - 12:15 p.m.       Open Public Hearing

·        Dr. Gunter Uhr – Curasan AG

·        Dr. Thomas Arrowsmith-Lowe – Regulatory Consultant for Curasan AG

·        Dr. Barbara Boyan – American Academy of Dental Research

·        Dr. Mark A. Reynolds – American Academy of Periodontology

 

12:15 - 1:15 p.m.         LUNCH

1:15 - 2:15 p.m.           Panel Presentation/Discussion

2:15 - 2:30 p.m.           BREAK

2:30 - 4:00 p.m.           Panel Recommendation and Classification

·        Ms. Marjorie Shulman, Consumer Safety Officer, FDA

4:00 p.m.                      CLOSED SESSION – Dental Branch Updates

4:30 p.m.                      MEETING ADJOURNED 

 

                                                   

 

CHAIR	EXECUTIVE SECRETARY
Leslie B. Heffez, DMD, MS Professor & Head, Oral/Maxillofacial Surgery University of Illinois, College of Dentistry Chicago, Illinois	Michael E. Adjodha, M.ChE. Department of Health and Human Services Food and Drug Administration         Center for Devices and Radiological Health Office of Device Evaluation Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices

                                                 

 

PANEL MEMBERS

 

         

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BACKGROUND

 

Dr. Vincent J. Morgan, President of Bicon, Inc., Boston, Massachusetts, submitted a petition to the FDA on November 12, 2002, to reclassify beta-tricalcium phosphate for dental indications.  Beta-tricalcium phosphate and all other forms of tricalcium phosphate, i.e., alpha, amorphous, etc., are transitional devices and are currently regulated for dental indications as a Class III devices under 21 CFR 872.3930, “Tricalcium Phosphate Granules for Dental Bone Repair.”  As modified on December 9, 2002, Dr. Morgan’s petition requests that beta-tricalcium phosphate be regulated as a Class II device.  Copies of the petition are available on FDA’s docket.  See http://www.fda.gov/ohrms/dockets/dailys/02/Dec02/121702/02p-0520.pdf. 

 

To address the petitioner’s request, the FDA has arranged to meet with a classification panel on May 22, 2003, in accordance with the procedures set forth for transitional devices (21 CFR 860.136), to reclassify 21 CFR 872.3930, the regulation to which beta tricalcium phosphate belongs.  For the purposes of this meeting, all forms of tricalcium phosphate, are subject to the proposed reclassification.

 

PANEL ACTION

 

At this meeting, the Dental Products Panel will discuss and vote on the following:

·                          Dr. Morgan’s petition,

·                          The risks of tricalcium phosphate (as defined in 21 CFR 872.3930),

·                          Any recommended controls for this device,

·                          A reclassification of the device, and

·                          Any recommended changes to the labeling and indications for use.

 

QUESTIONS FOR THE DENTAL PRODUCTS PANEL REGARDING THE PETITION TO RECLASSIFY TRICALCIUM PHOSHATE.

 

 

Dr. Vincent J. Morgan of Bicon, Inc., has submitted a petition to reclassify beta-tricalcium phosphate from Class III (Pre-Market Approval) to Class II (Special Controls).

 

Tricalcium phosphate is regulated as a Class III device under 21 CFR 872.3930, product code LPK, “Tricalcium Phosphate Granules for Dental Bone Repair.”  Please consider the following questions for Panel discussion.

 

1.                  Does the petition, as filed, adequately describe the risks to health of the device and provide for appropriate controls for these risks?  If yes, proceed to 3.  If no, go to 2.

 

2.                  a) What modifications would you make to the risks to health presented by the device?

b) What controls for these risks would provide a reasonable assurance of safety and effectiveness?  Proceed to 3.

 

3.                  Please complete the Classification Questionnaire and Supplemental Data Sheet for the device.  Completion of these forms will provide a formal recommendation for the reclassification of “Tricalcium Phosphate Granules for Dental Bone Repair.” (21 CFR 872.3930).  Proceed to 4.

 

4.                  Given your recommended classification, what changes, if any, would you recommend be made to the labeling (includes directions for use, indications, and contraindications) of these devices?