Clinical Perspective--Early Feasibility Device Medical Studies in the United States: Time for More Than Regulatory Reform.

Abstract

From the Department of Cardiovascular Diseases, May ter, Minnesota; FDA Center for Devices and Radiologi Spring, Maryland; FDA Office of Commissioner, Silver S Division of Cardiology, Columbia University Medical byterian Hospital, New York, New York; and Departm cular Surgery, Baylor Scott & White Health, Plano, Texa Clinical Perspective— Early Feasibility… (More)
DOI: 10.1016/j.jcin.2016.02.004

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Cite this paper

@article{Holmes2016ClinicalPF, title={Clinical Perspective--Early Feasibility Device Medical Studies in the United States: Time for More Than Regulatory Reform.}, author={David R. Holmes and Jeff Shuren and Robert M. Califf and Bram D Zuckerman and Dorothy B Abel and Andrew A. Farb and Martin B. Leon and Michael J. Mack}, journal={JACC. Cardiovascular interventions}, year={2016}, volume={9 6}, pages={626-8} }