FDA perspectives on postmarket surveillance of peripheral and aortic vascular devices

被引：0

作者：

Malone, Misti ^{[1
]}

Johnson, Carmen Gacchina ^{[1
]}

机构：

[1] US FDA, Off Cardiovasc Devices, Ctr Devices & Radiol Hlth, Silver Spring 20993, MD USA

来源：

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS | 2024年 / 104卷 / 01期

关键词：

D O I：

10.1002/ccd.31087

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Case examples in Pyun et al., highlight value of RWD to elucidate real-world outcomes in expanded patient population and to discern potential signals. CDRH actively engages with stakeholders through transparent communication and collaboration to resolve signals. Additional improvements in the RWD infrastructure are warranted to ensure complete and accurate data collection across the total product lifecycle.

引用

页码：170 / 171

页数：2

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