School of Pharmacy, Temple University, Philadelphia, PA, USA.
23andMe, Inc., Sunnyvale, CA, USA.
Ther Innov Regul Sci. 2024 Nov;58(6):1027-1030. doi: 10.1007/s43441-024-00685-8. Epub 2024 Aug 17.
The FDA published a final rule for Medical Devices; Laboratory Developed Tests in the Federal Register on May 6, 2024, which aims to ensure the safety and effectiveness of laboratory developed tests (LDTs) by amending current regulations. The rule also includes a policy to phase out the FDA's general enforcement discretion approach for LDTs, aligning them with other In Vitro Diagnostic Devices. Notably, direct-to-consumer (DTC) testing is exempt from this policy shift, as the FDA believes this category of tests has already met applicable requirements. This rule was first proposed in the Federal Register on October 3, 2023. The publication of this proposed rule sparked a considerable volume of public reactions during the comment period of the rule-making process, comprising general sentiment, key concerns, and suggestions. This commentary analyzes these concerns, particularly focusing on DTC tests, and offers recommendations, including reassessing the FDA's enforcement discretion for hybrid DTC tests, advocating for clear guidance on clinical oversight, and prioritizing a risk-based enforcement approach. Additionally, enhancing public education about the risks of DTC testing is crucial for safeguarding public health.
美国食品药品监督管理局（FDA）于 2024 年 5 月 6 日在《联邦公报》上发布了一项医疗器械；实验室开发的测试的最终规则，旨在通过修订现行法规来确保实验室开发的测试（LDT）的安全性和有效性。该规则还包括一项逐步淘汰 FDA 对 LDT 的一般执法自由裁量权的政策，使其与其他体外诊断设备保持一致。值得注意的是，直接面向消费者（DTC）的测试不受这一政策转变的影响，因为 FDA 认为此类测试已经符合适用要求。该规则最初于 2023 年 10 月 3 日在《联邦公报》上公布。该提案公布后，在规则制定过程的评论期内引发了大量公众反应，包括普遍情绪、主要关注点和建议。本评论分析了这些关注点，特别是针对 DTC 测试，并提出了建议，包括重新评估 FDA 对混合 DTC 测试的执法自由裁量权，倡导关于临床监督的明确指导，并优先采用基于风险的执法方法。此外，加强公众对 DTC 测试风险的教育对于保护公众健康至关重要。
