业界咨询后，终于在2024年4月29日出台了一项关于LDTs (Laboratory Developed Tests, 实验室设计项目)的新...
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，...
On May 6, 2024, the US Food and Drug Administration (FDA) finalized a new rule to regulate laboratory-developed tests (LDTs). An LDT is a reagent, instrument, or system used for diagnosis or treatment that is designed, manufactured, and used by a single laboratory.1LDTs a...
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...
The article provides information concerning the issue that laboratory-developed tests (LDTs) are subjected to Food & Drug Administration (FDA) review in the U.S. The FDA said commenters on the initial draft guidance issues in September 2006 misconstrued the scope of LDTs for which premarket ...
Laboratory developed tests (LDTs) will be regulated as medical devices following the announcement of the U.S. Food and Drug Administration's final rule on LDTs.
今年春季,美国食品药品监督管理局(FDA)公开宣布了其拟议规则的制定(The 2023 Spring RegulatoryAgenda of Regulatory and Deregulatory Actions),该规则明确将实验室开发的检验测试(Laboratory developedtests,“LDTs”)定义为医疗器械,并将其纳入该机构的监管权限。根据六月份拜登政府的《监管和放松管制行动统一议程》公布,...
laboratory." The move, which proposes adding language to21 CFR § 809.3, initiates notice-and-comment rulemaking on a matter garnering both strong opposition and support. If adopted, the rule would considerably shift FDA's approach to laboratory developed tests ("LDTs"), with significance not ...
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...
[1]FDA.Laboratory Developed Tests[EB/OL].[2019-05-20].https://www.fda.gov/medical-devices/vitro-diagnostics/laboratory-developed-tests. [2]Europa Commission.New regulations[EB/OL].[2019-05-20].http://ec.europa.eu/growth/sectors/medical-devices/new-regulations_en. ...