The Long and Winding Regulatory Road for Laboratory-Developed Tests

被引：25

作者：

Weiss, Ronald L. ^{[1
]}

机构：

[1] Univ Utah, Sch Med, Dept Pathol, ARUP Labs, Salt Lake City, UT 84108 USA

来源：

AMERICAN JOURNAL OF CLINICAL PATHOLOGY | 2012年 / 138卷 / 01期

关键词：

Laboratory-developed tests; In vitro diagnostic devices; Food and Drug Administration; Clinical Laboratory Improvement Amendments of 1988; Regulation; Personalized medicine;

D O I：

10.1309/AJCP6OAULC3CMFEJ

中图分类号：

R36 [病理学];

学科分类号：

100104 ;

摘要：

"High complexity" clinical laboratories are approved under the Clinical Laboratory Improvement Amendments to develop, validate, and offer a laboratory-developed test (LDT) for clinical use. The Food and Drug Administration considers LDTs to be medical devices under their regulatory jurisdiction, and that at least certain LDTs should be subject to greater regulatory scrutiny. This review describes the current regulatory framework for LDTs and suggests ways in which to appropriately enhance this framework

引用

页码：20 / 26

页数：7

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