Clinical Perspective – Early Feasibility Device Medical Studies in the US

In a recent Editor’s Page, published in JACC: Cardiovascular Interventions, David R. Holmes, Jr., MD, MACC, past-president of the ACC, Robert Califf, MD, MACC, commissioner of the U.S. Food and Drug Administration (FDA), et al., discuss early feasibility device medical studies in the U.S. According to the authors, “the FDA responded to the distinctive challenges of early device U.S. clinical studies with a program intended to transform the system for early device development—the Early Feasibility Study (EFS) Program …” They add that while the EFS initiative “allows patient access to early stage medical devices … on the basis of initial experiences with this program, a holistic rather than solely regulatory approach to modify the existing clinical trial infrastructure is necessary.” Read more.