@article{f5323fcea46d4be28326330b27bfa5d8,
title = "FDA Perspective on Clinical Trial Design for Cardiovascular Devices",
author = "Eric Chen and Wolf Sapirstein and Chul Ahn and Julie Swain and Bram Zuckerman",
note = "Funding Information: In a unique collaboration between academia, industry, and three US Department of Health and Human Services Agencies, National Institutes of Health, FDA, and CMS, an internet-based registry for all MCSD implants has been introduced that is supported by a National Heart, Lung, and Blood Institute grant. This registry promises to be a model for future post-market monitoring of innovative medical devices. The Interagency Registry for Mechanically Assisted Circulatory Support [ 6 ] will provide the robust active reporting of device performance that is often lacking with passive reporting such as the Medical Device Reporting and MedWatch programs that the FDA relies on at present. Participation by MCSD manufacturers is likely to address the post-marketing requirements of FDA and fulfill CMS requirements for reimbursement. The information generated from this registry will be valuable for defining additional applications for such devices and to direct future research. ",
year = "2006",
month = sep,
doi = "10.1016/j.athoracsur.2006.07.044",
language = "English",
volume = "82",
pages = "773--775",
journal = "Annals of Thoracic Surgery",
issn = "0003-4975",
publisher = "Elsevier Inc.",
number = "3",
}