@article{52f3f20f28dc4db8bd9fd87b07e4c103,
title = "Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States",
abstract = "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.",
keywords = "United States Food and Drug Administration, equipment design, new device development strategies, research design, research ethics committees",
author = "Holmes, {David R.} and Robert Califf and Andrew Farb and Dorothy Abel and Michael Mack and {Syrek Jensen}, Tamara and Bram Zuckerman and Martin Leon and Jeff Shuren",
note = "Funding Information: Dr. Califf currently holds the post of Commissioner of Food and Drugs, U.S. Food and Drug Administration; prior to his appointment to the FDA, Dr. Califf received research grant funding from the Patient-Centered Outcomes Research Institute, the National Institutes of Health, the U.S. Food and Drug Administration, Amylin, and Eli Lilly and Company; research grants and consulting payments from Bristol-Myers Squibb, Janssen Research and Development, Merck, and Novartis; received consulting payments from Amgen, Bayer Healthcare, BMEB Services, Genentech, GlaxoSmithKline, Heart.org/Daiichi-Sankyo, Kowa, Les Laboratoires Servier, Medscape/Heart.org , Regado, and Roche; and held equity in N30 Pharma and Portola. Dr. Mack has served as an uncompensated coprimary investigator of the Partner 3 and COAPT trials. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Robert Harrington, MD, served as Guest Editor for this paper. Publisher Copyright: {\textcopyright} 2016 American College of Cardiology Foundation",
year = "2016",
month = oct,
day = "25",
doi = "10.1016/j.jacc.2016.07.769",
language = "English (US)",
volume = "68",
pages = "1908--1915",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "17",
}