美国食品和药物管理局 (FDA) 拟议的规则对实验室开发的测试进行监管
Melissa B Miller1, Mary Lee Watts2, Linoj Samuel3
1Department of Pathology and Laboratory Medicine, UNC School of Medicine , Chapel Hill, North Carolina, USA.
Journal of clinical microbiology
|January 11, 2024
概括
美国食品和药物管理局 FDA
科学领域:
- 临床诊断 临床诊断 临床诊断
- 监管科学是一种监管科学.
- 公共卫生微生物学
背景情况:
- 美国食品和药物管理局 (FDA) 于2023年10月提出监管实验室开发的测试 (LDT).
- 这项拟议的规则将LDT从执法自由裁量权政策转变为类似于商业体外诊断 (IVD) 的监管.
研究的目的:
- 从临床和公共卫生微生物学实验室的角度概述有关FDA提出的LDT监管框架的担忧.
- 反对将LDT与商业IVD相同的监管,强调对患者护理和诊断创新的潜在负面影响.
主要方法:
- 作者对FDA关于LDT的拟议规则进行了批判性分析.
- 这个观点是基于临床和公共卫生微生物学实验室的经验和运营现实.
主要成果:
- 拟议的FDA规则可能会对诊断服务产生负面影响,抑制创新,并减少对测试和健康公平的访问.
- 为了支持拟议的监管要求,FDA和诊断实验室存在重大基础设施,人员和资金挑战.
结论:
- 由个人开发的LDT,临床实验室改进修改认证的实验室不应该面临与商业IVD相同的监管负担.
- 建议采用分阶段的方法,从注册流程和无负担的不良事件报告开始,以便在实施全面规则之前了解LDT环境.
- 监管规则必须以数据为导向,平衡患者安全与与传染病诊断相关的现实风险,并考虑对患者护理的潜在影响.
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