DRAFT AGENDA
Meeting of the
Microbiology Devices Panel Meeting
Friday, March 8, 2002

Panel Chair: Michael L. Wilson, M.D.
Executive Secretary/ Chief, Bacteriology Branch: Freddie M. Poole
Division Director: Steven I. Gutman, M.D., M.B.A.
 

 8:30    Call to Order

            Opening Remarks…………………..…………Executive Secretary
Introduction of Panel………………………….Panel Chair

            New Business

 Premarket Approval supplement: Digene High Risk HPV DNA

A nucleic acid hybridization in vitro diagnostic device for the detection of thirteen high-risk types of human papillomavirus (HPV) in cervical specimens. The test as modified is  indicated for use as a general population screening test in conjunction with the  Papanicolaou smear for women 30 years of age and older, as an aid to determine  the absence of high-grade cervical disease or cancer.

 9:00            Manufacturer’s Presentation:

                 Mark A. Del Vecchio……………………………..                                Tab #1
                 Director, Regulatory and Clinical Affairs, Digene Corporation

                 Atilla Lorincz, Ph.D………………………………                                 Tab #2
                 Senior Vice President and Chief Scientific officer, Digene Corporation

                 Jonathan Kahn, Esq……………………………….Summary                 Tab #3
                 Regulatory Consultant for Digene             
                
Partner, Hogan and Hartson, LLP

 10:15  Break

 10:25  Panel Discussant:

                Elizabeth Unger, Ph.D., M.D……………………………….
               
Chief, Human Papillomavirus Section, DVRD/NCID, CDC

                 Herschel Lawson, M.D……………………………………..
                Medical Advisor, Program Services Branch, DCPC, NCCDPHP, CDC

 10:45  Fda Presentation:

               Thomas E. Simms……………………………………………….FDA Issues

               Sr. Review Scientist, Virology Branch, DCLD

                Marina Kondratovich, Ph.D……………………………………Statistical Study
               Mathematical Statistician, Division of Biostatistics, Office of Surveillance & Biometrics,
               CDRH        

11:30   Open Public Hearing

 (Public Attendees who have contacted the Executive Secretary prior to the meeting, will address the panel and present information relevant to nucleic acid hybridization in vitro diagnostic devices for the detection of high-risk types of human papillomavirus (HPV) in cervical specimens.  Speakers are to state whether or not they have any financial involvement with manufacturers of these devices.)

12:00   Lunch Break

 1:00     Open Committee Discussion

 (This portion of the meeting is open to public observers. However, public observers may not participate except at the specific request of the Chairperson.)

 2:45     Break

 3:00     Open Public Hearing

(This portion of the meeting is open for comments from the public to comment on related issues.)

 3:30     Industry Response

               (The Sponsor may provide comments to respond to any issue raised during the Committee Discussion.)

3:35     Fda Response

              (The FDA may provide comments to respond to any issue raised during the Committee Discussion.)

3:40     Final Recommendations and Vote

            (The Panel will provide final recommendations to the FDA and vote on the PMA Supplement.)

 4:30     Adjourn