CRT slides: FDA on progress, challenges with Early Feasibility Study

WASHINGTON, D.C.—FDA researchers Andrew A. Farb, MD, and Dorothy B. Abel presented an overview about the potential for an FDA Early Feasibility Study pilot program in the U.S., recognizing a need for a cultural shift within the agency. However, evaluating the FDA guidance, they also recognized the challenges to the device evaluation strategy.

About the presenters:

Farb is a clinical cardiologist with additional training in pathology. He has been with Cardiovascular Specialists of Central Maryland, where he practices on a part-time basis, since 1989. He works full-time for the FDA in the interventional cardiology branch in the Office of Device Evaluation, and previously was a staff cardiologist and cardiovascular pathologist for the Armed Forces Institute of Pathology.

Abel has been a scientific reviewer in the peripheral vascular devices branch in the Office of Device Evaluation at the FDA since 1987, working primarily on vascular grafts and endovascular prostheses. In addition to her work at the FDA, Abel is the convener for the vascular prostheses working group for the International Organization of Standardization (ISO).