美国FDA 于 4 月 29 日发布了关于实验室自研检测(Laboratory Developed Test)的最终规章,旨在明确表明这类产品将作为医疗器械受到 FDA 监管。 FDA 对LDT的定义是旨在用于临床用途,并在满足某些监管要求的单一临床实验室内设计、制造和使用的体外诊断产品(In vitro Diagnostic Product,IVD)。IVD 可用于采集、制备和检查...
FDA宣布了一项最终规则,旨在帮助确保LDT(Laboratory Developed Test)的安全性和有效性。该规则明确LDT是体外诊断产品(IVD),是联邦食品、药物和化妆品法案(FD&C法案)下的器械。同时,FDA最终确定一项政策,将四年的时间里逐步取消其对LDT的一般执法自由裁量权,以及对实验室生产的某些类别的IVD有针对性的执法自由裁量权...
美国FDA 于 4 月 29 日发布了关于实验室自研检测(Laboratory Developed Test)的最终规章,旨在明确表明这类产品将作为医疗器械受到 FDA 监管。 FDA 对 LDT 的定义是旨在用于临床用途,并在满足某些监管要求的单一临床实验室内设计、制造和使用的体外诊断产品(In vitro Diagnostic Product,IVD)。IVD 可用于采集、制备和...
该项立法将会创建一个全新的基于风险的测试监管框架，将实验室开发测试 (Laboratory-developed test，简称 LTD) 和体外诊断（IVD）归为一类。然而，它也包括一些豁免：允许目前市场上的测试跳过新的上市前审查要求，除非做出了重大改变。行业团体和消费者权益保护团体对这项拟议法规持有反对意见。消费者权益倡导者表示，...
Tthe U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many yea...
If your laboratory has developed tests in-house (also known as "home brew" and now termed laboratory developed tests or LDTs) and changes proposed in Washington actually occur, these terms may become part of our everyday vocabulary. The FDA currently regulates most LDTs, through the reagents ...
tests. The U.S. Food and Drug Administration’s (FDA) recent final rule now explicitly designates Laboratory Developed Tests (LDTs) as devices under the Federal Food, Drug, and Cosmetic Act. This move aims to enhance the safety and effectiveness of LDTs used in a single clinical laboratory...
Regulation of laboratory-developed tests has been a subject of debate since at least the 1990s. Several federal advisory committees, including the Institute of Medicine, have recommended that the FDA exercise more authority over such testing. That's also been the position of diagnostic test manufactu...
Some more common tests—such as those used in hospitals, pharmacies, or doctors' offices to spotstrep throat, COVID-19, and other conditions—are already subject to premarketing FDA review. But thousands of so-called "laboratory developed tests" (LDTs), analyzed at many high-tech labs, face...
Contains Nonbinding Recommendations Draft - Not for Implementation 1 2 Draft Guidance for Industry, Food and 3 Drug Administration Staff, and Clinical 4 Laboratories 5 6 7 Framework for Regulatory Oversight of 8 Laboratory Developed Tests (LDTs) 9 10 DRAFT GUIDANCE 11 12 13 This guidance document...