NEW YORK – A decision from the US Food and Drug Administration announced earlier this year may significantly reduce the burden of garnering regulatory approval for companion diagnostic developers and some infectious disease assay developers, according to industry experts.

纽约——据行业专家称，美国食品和药物管理局今年早些时候宣布的一项决定可能会大大减轻伴随诊断开发商和一些传染病检测开发商获得监管部门批准的负担。

At the Next-Generation Dx Summit in Washington, DC this week, multiple industry stakeholders discussed the potential impact of the decision announced in January by the FDA's Center for Devices and Radiological Health. The CDRH said in a press release that it intends to reclassify most high-risk in vitro diagnostic devices — known as Class III devices — as moderate-risk devices, or Class II.

在本周于华盛顿举行的下一代Dx峰会上，多个行业利益相关者讨论了FDA设备与辐射健康中心1月份宣布的决定的潜在影响。CDRH在新闻稿中表示，它打算将大多数高风险体外诊断设备（称为III类设备）重新分类为中等风险设备或II类。

The majority of the tests included in this decision are companion diagnostic assays and microbiology tests, and the move would allow manufacturers to seek regulatory approval for their tests through a less-stringent regulatory pathway, the FDA said. .

FDA表示，该决定中包括的大多数检测是伴随诊断检测和微生物学检测，此举将允许制造商通过不太严格的监管途径寻求监管部门对其检测的批准。

The reclassification would allow these tests to obtain clearance through the 510(k) or de novo pathways rather than the higher burden of premarket approval. Approximately 5 percent of in vitro diagnostic devices are Class III and 45 percent are Class II, Christine Bump, a principal at Penn Avenue Law and Policy, said in a talk at the summit.

重新分类将允许这些测试通过510（k）或从头途径获得许可，而不是上市前批准的更高负担。宾夕法尼亚大道法律与政策学院校长克里斯蒂娜·邦普（ChristineBump）在峰会上的一次讲话中表示，大约5%的体外诊断设备为III类，45%为II类。

The majority of companion diagnostics, particularly those for cancer, are Class III devices, and the reclassification 'has the potential to lessen the premarket and clinical trial burdens' on developers of these tests, Bump said..

Bump说，大多数伴随诊断，特别是癌症诊断，都是III类设备，重新分类“有可能减轻这些测试开发人员的上市前和临床试验负担”。。

A device's class is determined by the risk, intended use, and technology used and establishes the exact requirements that apply to a device and its manufacturer. Class I devices require general controls, such as the registration of the manufacturing facility, compliance with labeling requirements, and post-market compliance, Bump said.

设备的类别由风险、预期用途和使用的技术决定，并确定适用于设备及其制造商的确切要求。Bump说，I类设备需要一般控制，例如生产设施的注册、标签要求的遵守以及上市后的遵守。

Class I devices are generally exempt from premarket review..

I类设备通常不受上市前审查。。

Class II devices require compliance with both general controls and special controls, and those special controls apply to all devices within that device type. Special controls include premarket data requirements, special labeling requirements, specific performance standards, and post-market surveillance.

II类设备要求符合一般控制和特殊控制，这些特殊控制适用于该设备类型内的所有设备。特殊控制包括上市前数据要求、特殊标签要求、特定性能标准和上市后监督。

A key component of the de novo process is establishing the special controls, which any device following the 510(k) pathway can then use, citing the de novo device as a predicate device..

从头过程的一个关键组成部分是建立特殊的控制，然后任何遵循510（k）路径的设备都可以使用，引用从头设备作为谓词设备。。

However, a Class III device exists in a 'vacuum,' meaning every device that goes through the premarket approval process is responsible for independently providing data and information to provide the reasonable assurance of safety and effectiveness.

然而，III类设备存在于“真空”中，这意味着每个经过上市前批准流程的设备都有责任独立提供数据和信息，以提供合理的安全性和有效性保证。

Courtney Lias, director of the FDA's Office of In Vitro Diagnostics, said in a separate talk at the summit that the agency has learned enough about these test types to enable the FDA to craft special controls that can mitigate the risks enough to allow 510(k) approval. She added that the reclassification process may provide more incentive for smaller players in the industry to seek regulatory approval because it will be easier to manage allow for more predictability in the regulatory process, and lower costs.

FDA体外诊断办公室主任考特尼·利亚斯（CourtneyLias）在峰会上的另一次讲话中表示，该机构已经对这些测试类型有了足够的了解，从而使FDA能够制定特殊的控制措施，以减轻足够的风险，从而获得510（k）的批准。她补充说，重新分类过程可能会为行业中较小的参与者寻求监管批准提供更多激励，因为它将更容易管理，从而使监管过程具有更高的可预测性，并降低成本。

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The agency began the reclassification process in September 2023 with a panel of microbiology experts who were presented with three device types — assays for hepatitis B, Mycobacterium tuberculosis, and parvovirus B19 — and discussed the possibility of their reclassification. The panel found that there was enough evidence to proceed with reclassification of the latter two tests, Bump said.

该机构于2023年9月与一组微生物学专家开始了重新分类过程，他们被介绍了三种设备类型-乙型肝炎，结核分枝杆菌和细小病毒B19的检测-并讨论了重新分类的可能性。。

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To reclassify a test from Class III to Class II, the available scientific evidence must show that special and general controls are sufficient to provide reasonable assurance of safety and effectiveness, Bump said. The reclassification will apply to the broader device type and not an individual test, she noted..

Bump说，要将测试从III级重新分类为II级，现有的科学证据必须表明，特殊和一般控制足以提供合理的安全性和有效性保证。她指出，重新分类将适用于更广泛的设备类型，而不是单独的测试。。

Generally, the reclassification process requires the publication of a proposed administrative order in the Federal Register that includes details about each type of device the agency would like to reclassify and a summary of the scientific evidence that supports reclassification, Bump noted. The FDA will then convene a device classification panel meeting for every general category of devices it aims to reclassify.

Bump指出，一般来说，重新分类过程需要在《联邦公报》中公布拟议的行政命令，其中包括该机构想要重新分类的每种类型的设备的详细信息，以及支持重新分类的科学证据的摘要。然后，FDA将为其旨在重新分类的每一类设备召开一次设备分类小组会议。

These meetings are open to the public and the panel then makes a recommendation to the agency, although the FDA is not required to follow the recommendation. The agency will also consider public comments from the proposed order and then publish a final administrative order in the Federal Register, Bump said.

这些会议对公众开放，然后专家组向该机构提出建议，尽管FDA不需要遵循该建议。Bump说，该机构还将考虑公众对拟议命令的评论，然后在《联邦公报》上发布最终行政命令。

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The reclassification plan, despite being announced before the publication of the agency's final rule laying out its plan for overseeing laboratory-developed tests, likely is related to the FDA's LDT decision, Bump said. A large amount of LDTs would potentially be Class III devices, and having to move all of those through the premarket approval process would be 'literally impossible,' she said, adding that 'onerously burdensome doesn't even begin to describe' the impact.

Bump说，尽管重新分类计划是在该机构制定监督实验室开发测试计划的最终规则发布之前宣布的，但可能与FDA的LDT决定有关。。

If the LDT final rule remains in effect — which is not a guarantee, considering both the American Clinical Laboratory Association and the Association for Molecular Pathology have sued the FDA over the rule — the reclassification process would lessen the burden on both laboratories and the FDA, Bump noted..

Bump指出，如果LDT最终规则仍然有效（考虑到美国临床实验室协会和分子病理学协会都已就此规则起诉FDA，这并不能保证），那么重新分类过程将减轻实验室和FDA的负担。。

The agency anticipates the reclassification process will be complete by November 2027, but historically, the process has taken a long time, and it is a 'huge goal' to do all of this by that date, she added.

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The FDA has also provided little additional information about how the process will work, particularly for complex companion diagnostic tests.

FDA也没有提供关于该过程如何工作的更多信息，特别是对于复杂的伴随诊断测试。

Kate Simon, senior director of global regulatory strategy for in vitro diagnostics at Bayer and a former FDA employee, said in a separate presentation at the summit that the level of burden for validation studies for a companion diagnostic is not driven by whether the device is submitting for premarket approval, de novo, or 510(k), but by the best practices for the performance characteristics of the device.

拜耳（Bayer）体外诊断全球监管战略高级主管、前FDA员工凯特·西蒙（Kate Simon）在峰会上的另一次演讲中表示，配套诊断验证研究的负担程度并不取决于该设备是否提交上市前批准、从头批准或510（k），而是取决于该设备性能特征的最佳实践。

'Since IVD devices that are currently regulated as PMAs tend to involve more complex clinical issues, the clinical studies tend to be more complex as well,' she noted..

她指出：“由于目前受PMA监管的IVD设备往往涉及更复杂的临床问题，因此临床研究也往往更复杂。”。。

However, she noted for a PMA submission a sponsor must establish independent safety and effectiveness, whereas for a 510(k) submission a device can establish substantial equivalence to a predicate device. 'How FDA will approach substantial equivalence for CDx [tests] versus safety and effectiveness in regards to validation data remains to be seen,' she noted..

然而，她指出，对于PMA提交，赞助商必须建立独立的安全性和有效性，而对于510（k）提交，设备可以建立与谓词设备的实质等效性。”她指出，FDA将如何在验证数据方面实现CDx[测试]与安全性和有效性的实质等效性仍有待观察。。

In addition, there is no option for modular submission under the 510(k) pathway, which CDx developers use to enable review of their submissions under tight timelines, Simon said. These submissions allow applicants to submit preclinical data and manufacturing information for review while still collecting, compiling, and analyzing clinical trial data.

此外，在510（k）路径下没有模块化提交的选项，CDx开发人员使用510（k）路径可以在严格的时间表下审查他们的提交，西蒙说。这些提交允许申请人提交临床前数据和制造信息以供审查，同时仍在收集，编译和分析临床试验数据。

The move to 510(k) clearance for companion diagnostics may limit the FDA's ability to review submissions under accelerated timelines because the agency may not accept preclinical data before the device's clinical validation data, Simon added..

Simon补充道，将配套诊断的许可证提高到510（k）可能会限制FDA在加速时间表下审查提交文件的能力，因为该机构可能不接受设备临床验证数据之前的临床前数据。。