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

共 50 条

[1] Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi, Vinay K.
Krumholz, Harlan M.
Masoudi, Frederick A.
Ross, Joseph S.
[J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2015, 314 (06): : 604 - 612
[2] Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014
Rathi, Vinay K.
Wang, Bo
Ross, Joseph S.
Downing, Nicholas S.
Kesselheim, Aaron S.
Gray, Stacey T.
[J]. OTOLARYNGOLOGY-HEAD AND NECK SURGERY, 2017, 156 (02) : 285 - 288
[3] Comparison of Priority vs Standard US Food and Drug Administration Premarket Approval Review for High-Risk Medical Devices
Ong, Caroline
Ly, Vy K.
Redberg, Rita F.
[J]. JAMA INTERNAL MEDICINE, 2020, 180 (05) : 801 - 803
[4] Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications
Lee, Samuel J.
Cho, Lauren
Klang, Eyal
Wall, James
Rensi, Stefano
Glicksberg, Benjamin S.
[J]. JAMA NETWORK OPEN, 2021, 4 (06) : E2112562
[5] Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration
Rathi, Vinay K.
Ross, Joseph S.
Samuel, Andre M.
Mehra, Saral
[J]. OTOLARYNGOLOGY-HEAD AND NECK SURGERY, 2015, 153 (03) : 400 - 408
[6] Analysis of Benefit-risk Balance in Decision-making of the Food and Drug Administration for Premarket Approval of Therapeutic Medical Devices
Muragaki, Yoshihiro
Uematsu, Miyuki
Iseki, Hiroshi
Umezu, Mitsuo
[J]. ADVANCED BIOMEDICAL ENGINEERING, 2013, 2 : 101 - 106
[7] The US Food and Drug Administration's expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation
Wallach, Joshua D.
Ross, Joseph S.
Naci, Huseyin
[J]. CLINICAL TRIALS, 2018, 15 (03) : 243 - 246
[8] Gender Bias in Studies for Food and Drug Administration Premarket Approval of Cardiovascular Devices
Dhruva, Sanket S.
Bero, Lisa A.
Redberg, Rita F.
[J]. CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES, 2011, 4 (02): : 165 - U49
[9] Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018
Rathi, Vinay K.
Johnston, James L.
Dhruva, Sanket
Ross, Joseph
[J]. BMJ SURGERY INTERVENTIONS & HEALTH TECHNOLOGIES, 2023, 5 (01)
[10] Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements
Zheng, Sarah Y.
Dhruva, Sanket S.
Redberg, Rita F.
[J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2017, 318 (07): : 619 - 625

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