> 1:00 p.m. Start Time

Moderator
M. Elizabeth Bierman, Morgan, Lewis & Bockius LLP

> Welcome and Introductions

> Donna-Bea Tillman, FDA:

• History of FDA’s regulation of computer/software products
• Review of proposed rule
• Anticipated impact of the rulemaking for future computer/software products

> Questions-and-Answers
(moderator to pose questions to panelists)

> Questions from sites

> 2:30 p.m. Conclusion

M. ELIZABETH (BETH) BIERMAN is a Partner in the Food and Drug Administration (FDA)/Healthcare Regulation Practice at Morgan Lewis. Ms. Bierman has more than 20 years of experience in representing domestic and international companies with respect to all FDA regulatory and compliance matters relating to the development, manufacturing, and marketing of medical devices, pharmaceuticals, biologicals, and combination products. Ms. Bierman has counseled extensively on jurisdictional issues and regulatory pathway strategies for FDA-regulated products; assisted clients in preparing medical device product applications and other regulatory submissions; conducted FDA regulatory due diligence; and advised on medical device postmarket compliance issues.   She has spoken on medical device regulatory issues at industry conferences and written several articles on medical device issues for industry publications.

LARRY A. KROGER, Ph.D., is Senior Regulatory Programs Manager at GE Healthcare located in Waukesha, WI. Dr. Kroger has held several positions at GE related to managing the compliance of GE products with the U.S. Food, Drug, and Cosmetic Act, the U.S. Radiation Control for Health and Safety Act, the European Medical Device Directive, and various other non-U.S. medical device laws.  His responsibilities have included certification of electronic radiation-emitting products to federal performance standards, compliance of the GE quality system to global standards and regulations, and submission of more than 300 marketing applications.  He was responsible for obtaining Food and Drug Administration (FDA) premarket approval and reclassification of GE magnetic resonance imaging systems.  He has served as chairman of both the Technical and Regulatory Committee and the Diagnostic X-Ray Section in the Medical Imaging and Technology Alliance (MITA) division of the National Electrical Manufacturers Association and is a member of Study Group 2 of the Global Harmonization Task Force.  He was formerly Senior Physicist at the Emergency Care Research Institute in Plymouth Meeting, PA, where he conducted medical product evaluations and consulted with healthcare institutions regarding medical device issues.  Dr. Kroger received his B.A. in math and physics from Hastings College in Nebraska and his Ph.D. in physics from the University of Wyoming.

DONNA-BEA TILLMAN, Ph.D. is the Director of the Office of Device Evaluation (ODE) in the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA). She oversees the premarket review program for medical devices.  She began her career at FDA in 1994 as a Reviewer in the OB/GYN devices branch, and later went on to become Branch Chief of the Pacing and Electrophysiology Devices Branch, and Deputy Director for the Division of Cardiovascular Devices.  In October 2003, she became the ODE Deputy Director for Technology and Review Policy.  Prior to coming to FDA, Dr. Tillman was involved in developing consensus standards at the Consumer Product Safety Commission.  She received her Bachelor of Science in Engineering from Tulane University, and her Ph.D. in Biomedical Engineering from the Johns Hopkins University.