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首页> 外文期刊>Journal of Clinical Microbiology >Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests
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Point-Counterpoint: The FDA Has a Role in Regulation of Laboratory-Developed Tests

机译：点对点：FDA在监管实验室开发的测试中发挥作用

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Since the Food and Drug Administration (FDA) released its draft guidance on the regulation of laboratory-developed tests (LDTs) in October 2014, there has been a flurry of responses from commercial and hospital-based laboratory directors, clinicians, professional organizations, and diagnostic companies. The FDA defines an LDT as an “in vitro diagnostic device that is intended for clinical use and is designed, manufactured, and used within a single laboratory.” The draft guidance outlines a risk-based approach, with oversight of high-risk and moderate-risk tests being phased in over 9 years. High-risk tests would be regulated first and require premarket approval. Subsequently, moderate-risk tests would require a 510(k) premarket submission to the FDA and low-risk tests would need only to be registered. Oversight discretion would be exercised for LDTs focused on rare diseases (defined as fewer than 4,000 tests, not cases, per year nationally) and unmet clinical needs (defined as those tests for which there is no alternative FDA-cleared or -approved test). There was an open comment period followed by a public hearing in early January of 2015, and we are currently awaiting the final decision regarding the regulation of LDTs. Given that LDTs have been developed by many laboratories and are essential for the diagnosis and monitoring of an array of infectious diseases, changes in their regulation will have far-reaching implications for clinical microbiology laboratories. In this Point-Counterpoint, Angela Caliendo discusses the potential benefits of the FDA guidance for LDTs whereas Kim Hanson discusses the concerns associated with implementing the guidance and why these regulations may not improve clinical care.
机译：自美国食品药品监督管理局（FDA）在2014年10月发布其关于实验室开发的测试（LDT）法规的指导草案以来，商业和医院实验室主任，临床医生，专业组织以及诊断公司。 FDA将LDT定义为“用于临床用途的“ 体外”诊断设备，该设备是在单个实验室中设计，制造和使用的。指南草案概述了基于风险的方法，对高风险和中风险测试的监督将在9年内分阶段进行。高风险测试将首先受到监管，并需要获得上市前批准。随后，中度风险测试将需要向FDA提交510（k）上市前申报，而低风险测试仅需注册。对于侧重于罕见病（全国每年定义少于4,000种测试，而不是病例）和未满足临床需求（定义为没有FDA批准或认可的测试的测试）的LDT，将行使监督酌处权。公众意见征询期开放，随后于2015年1月上旬举行公开听证会，我们目前正在等待有关LDT法规的最终决定。鉴于LDT已由许多实验室开发，并且对于诊断和监测一系列传染病至关重要，因此其法规的变化将对临床微生物学实验室产生深远的影响。在本要点中，Angela Caliendo讨论了FDA指南对LDT的潜在好处，而Kim Hanson讨论了与实施指南相关的问题以及这些法规为何不能改善临床护理。

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