Regulatory hurdles in bringing an in vitro diagnostic device to market

被引：0
作者：
Smith, KM
Kates, JA
机构：
来源：
CLINICAL CHEMISTRY | 1996年 / 42卷 / 09期
关键词：
D O I：
暂无
中图分类号：
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号：
1001 ;
摘要：
We discuss the hurdles that developers and manufacturers of in vitro diagnostic devices face in obtaining regulatory approval to market their products in the US, A thorough understanding of medical device regulation and the early planning of a clinical and regulatory strategy are imperative in assuring successful and timely launches of new products. Finally, it is critical for manufacturers to establish a working partnership with the Food and Drug Administration to expedite their new product applications.
引用
收藏
页码：1556 / 1557
页数：2
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