Presentation Title: The FDA and Medical Device Regulation: Challenges and Opportunities

Donna R. Lochner is Deputy Director of the Food and Drug Administration's Division of Cardiovascular Devices. Her primary responsibilities include the review and approval of cardiovascular medical devices distributed or clinically investigated in the U.S. She has management oversight over the Circulatory Support and Prosthetic Devices Branch, Interventional Cardiology Devices Branch and Peripheral Vascular Devices Branch. She has also served as the Chief of FDA's Intraocular and Corneal Implants Branch. Prior to joining the FDA, Ms. Lochner worked in regulatory affairs and engineering for Cordis Corporation. She has a B.S. in chemical engineering from the Pennsylvania State University.