FDA regulation of cardiovascular devices and opportunities for improvement

被引：12

作者：

Dhruva, Sanket S. ^{[1
]}

Redberg, Rita F. ^{[2
]}

机构：

[1] Univ Calif Davis, Dept Internal Med, Div Cardiol, Davis, CA 95616 USA

[2] Univ Calif San Francisco, Dept Med, Div Cardiol, San Francisco, CA 94143 USA

来源：

JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY | 2013年 / 36卷 / 02期

关键词：

Cardiovascular devices; Cardiovascular disease; FDA; Medical device regulation; IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS; MEDICAL DEVICES; POSTMARKETING SURVEILLANCE; PREMARKET APPROVAL; THERAPY; TRIALS; WOMEN; OUTCOMES; FAILURE; RECALLS;

D O I：

10.1007/s10840-012-9767-1

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Medical devices are of increasing importance in cardiovascular disease and have made important contributions to patient care. These devices continue to evolve with increasing complexity. FDA regulation of medical devices involves increased stringency for higher risk and novel devices. However, there are some current opportunities to strengthen the FDA's pre-approval regulatory process and improve post-marketing surveillance. This article reviews FDA regulation of cardiovascular devices and offers suggestions for strengthening the process while focusing on examples relevant to cardiac electrophysiologists.

引用

页码：99 / 105

页数：7

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