DRAFT

Agenda

Radiological Devices Panel Meeting

 

December 10, 2002

 

Purpose of the Meeting - To discuss, make recommendations and vote on a premarket approval application (PMA P010035) for a device that produces a computerized thermal image of the breast of women recommended for biopsy.

 

8:30 - 8:45                   Call to order and the Chair’s Introduction – Minesh P. Mehta, M.D.   

                                    Update on FDA Radiology Activities - Robert A. Phillips, Ph.D.     FDA Introductory Remarks - Robert J. Doyle, Executive Secretary

 

8:45 - 9:15                   Development of Amendments to the U.S. Radiation Safety Standard for Diagnostic X-Ray Computed Tomography - Stanley Stern, Ph.D. 

 

Open Public Hearing

 

9:15 – 9:45                  Open Public Hearing

                                                 

 

Open Committee Discussion

 

9:45  - 9:50                  Charge to the Panel - Minesh P. Mehta, M.D.

 

9:50 - 11:10                 Presentations on P010035 by sponsor

 

-                      Introduction - John Brenna 

-                      Clinical Use - Yuri Parisky, M.D.

-                      Engineering and Technical - Lynn Satterthwaite

-                      Clinical Trial and Results - Karleen Callahan, M.D.

-                      Statistics - Steve Rust, Ph.D.

-                      Clinical Results and Use - Elizabeth Nelson

-                      Clinical Use - Kevin Hughes, M.D.

 

11:10 - 12:00               Presentations on P010035 by FDA

 

-                      PMA Overview -  John Monahan

-                      Clinical Review - William Sacks, Ph.D., M.D.

-                      Statistical Analysis - Harry Bushar, Ph.D.

-                      Clinical Review continued - William Sacks, Ph.D., M.D.

 

12:00 - 1:00                 Lunch                       

 

 

Closed Session

 

12:30 - 1:00                 Closed Session, Branch Actions - Robert A. Phillips, Ph.D.

 

 

Open Committee Discussion

 

1:00 - 3:00                   Panel Discussion

 

3:00 - 3:15                   Break

 

Open Public Hearing

 

3:15 - 3:45                   Open Public Hearing

 

Open Committee Deliberations

 

3:45 – 5:00                  Panel Recommendation(s) and vote

 

5:00                             Adjourn