What is involved in a regulatory trial investigating a new medical device?

被引：0

作者：

McKay, Paula J. ^{[1
]}

Resendes, Sarah ^{[1
]}

Schemitsch, Emil ^{[3
]}

Bhandari, Mohit ^{[1
,2
,4
]}

机构：

[1] Department of Surgery, McMaster University, Hamilton, ON

[2] Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON

[3] Division of Orthopaedic Surgery, University of Toronto, Toronto, ON

[4] Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON L8L 8E7

来源：

Journal of Long-Term Effects of Medical Implants | 2007年 / 17卷 / 02期

关键词：

FDA; Regulatory trials; Study design;

D O I：

10.1615/JLongTermEffMedImplants.v17.i2.90

中图分类号：

学科分类号：

摘要：

Regulatory trials allow for the clinical evaluation of new drugs and medical devices, determining whether or not they can be safely and effectively used in patient care. The outcome of these trials may result in new and better ways of preventing, diagnosing, and treating illness. However, conducting a regulatory trial to evaluate a new medical device is a complex and time-intensive process involving many parties. This paper will provide an overview of the regulatory approval process for medical devices in the United States and will discuss what is involved in conducting a regulatory trial investigating a new device. © 2007 by Begell House, Inc.

引用

页码：165 / 171

页数：6