Dept of Pathology, University of Utah School of Medicine, ARUP Laboratories, 500 Chipeta Way, Salt Lake City, UT 84108, USA.
Am J Clin Pathol. 2012 Jul;138(1):20-6. doi: 10.1309/AJCP6OAULC3CMFEJ.
"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.
“高复杂性”临床实验室根据《临床实验室改进修正案》获得批准，以开发、验证和提供用于临床用途的实验室自建检测（LDT）。食品和药物管理局认为 LDT 属于其监管范围内的医疗器械，至少某些 LDT 应受到更严格的监管审查。本综述描述了当前 LDT 的监管框架，并提出了适当加强该框架的方法。
