The Food and Drug Administration's Unique Device Identification System Better Postmarket Data on the Safety and Effectiveness of Medical Devices

被引：15

作者：

Rising, Josh ^{[1
]}

Moscovitch, Ben ^{[1
]}

机构：

[1] Pew Charitable Trusts, Washington, DC 20004 USA

来源：

JAMA INTERNAL MEDICINE | 2014年 / 174卷 / 11期

关键词：

D O I：

10.1001/jamainternmed.2014.4195

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

引用

页码：1719 / 1720

页数：2

共 50 条

[1] Unique device identifiers for coronary stent postmarket surveillance and research: A report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier Demonstration
Tcheng, James E.
Crowley, Jay
Tomes, Madris
Reed, Terrie L.
Dudas, Joseph M.
Thompson, Kweli P.
Garratt, Kirk N.
Drozda, Joseph P., Jr.
AMERICAN HEART JOURNAL, 2014, 168 (04) : 405 - +
[2] Assessment of Data Sources That Support US Food and Drug Administration Medical Devices Safety Communications
Tau, Noam
Shepshelovich, Daniel
JAMA INTERNAL MEDICINE, 2020, 180 (11) : 1420 - 1426
[3] Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation
Malinauskas, Richard A.
Saha, Anindita
Sheldon, Murray I.
ARTIFICIAL ORGANS, 2015, 39 (04) : 293 - 299
[4] Benefits and pitfalls of food and drug administration summary of safety and effectiveness data and manufacturer and user facility device experience database related to endometrial ablation devices
Gimpelson, Richard
OBSTETRICS AND GYNECOLOGY, 2006, 107 (04): : 21S - 22S
[5] Primer on medical device regulation .2. Regulation of medical devices by the US Food and Drug Administration
Monsein, LH
RADIOLOGY, 1997, 205 (01) : 10 - 18
[6] Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care
Wilson, Natalia A.
Tcheng, James E.
Graham, Jove
Drozda, Joseph P., Jr.
MEDICAL DEVICES-EVIDENCE AND RESEARCH, 2021, 14 : 411 - 421
[7] Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011
Rathi, Vinay K.
Krumholz, Harlan M.
Masoudi, Frederick A.
Ross, Joseph S.
JAMA NETWORK OPEN, 2020, 3 (08)
[8] Safety evaluation of medical devices: US Food and Drug Administration and International Standards Organization guidelines
Northup, SJ
INTERNATIONAL JOURNAL OF TOXICOLOGY, 1999, 18 (04) : 275 - 283
[9] The US Food and Drug Administration's Approach for Safe Innovation of Medical Devices in Dermatology
Chang, Cynthia J.
Ashar, Binita S.
Marquart, Laura N.
JAMA DERMATOLOGY, 2018, 154 (03) : 261 - 263
[10] US Food and Drug Administration Regulation of Medical Devices and Radiation Oncology: Can Reform Improve Safety?
Hattangadi, Jona A.
O'Reilly, James T.
Recht, Abram
JOURNAL OF ONCOLOGY PRACTICE, 2012, 8 (01) : 53 - 56

← 1 2 3 4 5 →