Scientific Publications by FDA Staff

J Am Coll Cardiol 2016 Oct 25;68(17):1908-15

Overcoming the challenges of conducting early feasibility studies of medical devices in the United States.

Holmes DR Jr, Califf R, Farb A, Abel D, Mack M, Syrek Jensen T, Zuckerman B, Leon M, Shuren J

Initial clinical studies of new medical technologies involve a complex balance of research participant benefits versus risks and costs of uncertainty when novel concepts are tested. The Food and Drug Administration Center for Devices and Radiological Health has recently introduced the Early Feasibility Study (EFS) Program for facilitating the conduct of these studies under the Investigational Device Exemption regulations. However, a systematic approach is needed to successfully implement this program while affording appropriate preservation of the rights and interests of patients. For this to succeed, a holistic reform of the clinical studies ecosystem for performing early-stage clinical research in the United States is necessary. The authors review the current landscape of the U.S. EFS and make recommendations for developing an efficient EFS process to meet the goal of improving access to early-stage, potentially beneficial medical devices in the United States.