Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011

被引：8

作者：

Rathi, Vinay K. ^{[1
]}

Krumholz, Harlan M. ^{[2
,3
,4
]}

Masoudi, Frederick A. ^{[5
,6
]}

Ross, Joseph S. ^{[3
,4
,7
]}

机构：

[1] Massachusetts Eye & Ear, Dept Otolaryngol, 243 Charles St, Boston, MA 02114 USA

[2] Yale Univ, Sch Med, Dept Internal Med, Sect Cardiovasc Med, New Haven, CT 06510 USA

[3] Yale Univ, Dept Hlth Policy & Management, Sch Publ Hlth, New Haven, CT USA

[4] Yale New Haven Med Ctr, Ctr Outcomes Res & Evaluat, 20 York St, New Haven, CT 06504 USA

[5] Univ Colorado, Div Cardiol, Anschutz Med Campus, Aurora, CO USA

[6] Colorado Cardiovasc Outcomes Res Consortium, Denver, CO USA

[7] Yale Univ, Sch Med, Dept Internal Med, Sect Gen Internal Med, New Haven, CT 06510 USA

来源：

JAMA NETWORK OPEN | 2020年 / 3卷 / 08期

关键词：

D O I：

10.1001/jamanetworkopen.2020.14496

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

This cross-sectional study provides a 5-year update on the status and availability of postmarket evidence for high-risk medical devices that received FDA premarket approval in 2010 and 2011.

引用

页数：4

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