DAY ONE

7:00 REGISTRATION & CONTINENTAL BREAKFAST

7:50 CHAIRPERSON'S OPENING REMARKS

8:00 IMPROVING TRANSPARENCY AND COMMUNICATION BETWEEN THE AGENCY AND THE MEDICAL DEVICE INDUSTRY
David Vanella
Senior Vice President, Quality Systems
RENAL SOLUTIONS

8:50 ACHIEVING A BETTER UNDERSTANDING OF HOW FDA DETERMINES SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICES
Bruce Prothro
Chief Regulatory Officer and Senior Vice President, Quality Systems and Assurance
ARTHROCARE

9:40 COFFEE & NETWORKING BREAK

10:00 PANEL DISCUSSION: ASSURANCE CASE REPORTS AND THEIR IMPACT ON THE 510(K) SUBMISSIONS
Richard C. Chapman, BA, MS, Chief, General Hospital Devices Branch, Division of Anesthesiology, General Hospital, Infection Control & Dental Devices, Center for Devices & Radiological Health
FOOD & DRUG ADMINISTRATION
Ray Silkaitis, RPh, PhD, Director, Device Development GRA
HOSPIRA
Pat Baird, Systems Specialist
BAXTER HEALTHCARE

10:50 UNDERSTANDING CHANGES TO THE 510(K) REGULATORY PATHWAY
Christy Foreman, Director, Office of Device Evaluation, Center for Devices and Radiological Health
FOOD AND DRUG ADMINISTRATION
Mary K. Moore, Vice President, Regulatory Affairs
SONOSITE, INC.

12:10 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS

1:40 BREAKOUT SESSIONS: AN EXCHANGE OF IDEAS

2:30 COFFEE & NETWORKING BREAK

2:40 LESSONS LEARNED: EVOLVING BUT STILL CONSTANT
REQUIREMENTS TO GAIN PMA APPROVAL
Philip Lavin, PhD, Executive Vice President, Medical Devices
APTIV SOLUTIONS

3:30 COFFEE & NETWORKING BREAK

3:50 FDA’S PERSPECTIVE ON THE TRADITIONAL AND MODULAR PMA REGULATORY PATHWAYS

Nicole Wolanski, Director, Premarket Approval Section, Center for Devices & Radiological Health
FOOD AND DRUG ADMINISTRATION

4:40 COMPREHENDING FDA’S REGULATORY APPROVAL PROCESS FOR COMBINATION PRODUCTS
Marguerite Eras, Associate Director, Regulatory Affairs
ABBOTT VASCULAR

5:30 DAY ONE OF CONFERENCE CONCLUDES