NEW YORK – The US Food and Drug Administration has issued a draft guidance detailing its proposed policies for predetermined change control plans (PCCPs) for medical devices.

纽约——美国食品和药物管理局（FDA）发布了一份指南草案，详细说明了其针对医疗器械的预定变更控制计划（PCCP）的拟议政策。

The guidance will likely prove of interest to the clinical laboratory industry, which has identified PCCPs as potential source of flexibility for modifying and updating laboratory-developed tests (LDTs) following the FDA's recently issued final rule on regulating these assays.

临床实验室行业可能会对该指南感兴趣，根据FDA最近发布的关于规范这些检测的最终规则，该行业已将PCCP确定为修改和更新实验室开发检测（LDT）的潜在灵活性来源。

Codified in the Food and Drug Omnibus Reform Act of 2022 (FDORA), PCCPs allow manufacturers to make certain changes and updates to FDA-cleared or approved devices without having to take them back through the regulatory process.

PCCP被编入《2022年食品和药物综合改革法案》（FDORA），允许制造商对FDA批准或批准的设备进行某些更改和更新，而无需通过监管程序将其收回。

A PCCP is documentation submitted as part of a device's larger regulatory package that details future changes or updates a manufacturer may want to make to the device as well as how those changes will be implemented and validated. If approved, the PCCP allows the manufacturer to make those changes without having to take the device back through premarket review..

PCCP是作为设备较大监管包的一部分提交的文档，详细说明制造商可能希望对设备进行的未来更改或更新，以及如何实施和验证这些更改。如果获得批准，PCCP允许制造商进行这些更改，而无需通过上市前审查将设备收回。。

PCCPs have commonly been discussed as a tool for updating software and AI-based devices, but they are applicable to diagnostics more broadly, and FDA's move to exert authority over LDTs has driven interest in PCCPs among some clinical labs and laboratorians.

PCCP通常被认为是更新软件和基于AI的设备的工具，但它们适用于更广泛的诊断，而FDA对LDT行使权力的举动引起了一些临床实验室和实验室对PCCP的兴趣。

Examples of where PCCPs might be used include a manufacturer adding a new strain to a previously cleared flu test or a new genetic variant to a genetic test. Exactly what the scope of PCCPs will be has remained uncertain, however.

可能使用PCCP的例子包括制造商在先前清除的流感检测中添加新菌株或在基因检测中添加新基因变异。然而，PCCP的具体范围仍不确定。

The new draft guidance remains somewhat vague on exactly what modifications might be covered under a PCCP, but it does provide some details. For instance, 'certain changes in the labeling and/or the indications for use to specify use of the device with an additional device, component, or human genetic variant' may be appropriate for inclusion in a PCCP.

新的指导草案对于PCCP可能涵盖的具体修改内容仍然有些模糊，但它确实提供了一些细节。例如，“标签的某些变化和/或用于指定使用带有其他设备，组件或人类遗传变异的设备的指示”可能适合包含在PCCP中。

On the other hand, 'changes in the labeling and/or the indications for use to include a new patient population' are 'generally not appropriate,' for inclusion, the guidance states. Broadly speaking, the guidance indicates that modifications are not appropriate for inclusion in a PCCP if they introduce a 'major change' to a device's intended use, 'significantly affect' its safety or effectiveness, or introduce a new risk..

另一方面，指南指出，“标签和/或用于包括新患者群体的适应症的变化”通常不适合纳入。从广义上讲，指南表明，如果修改对设备的预期用途产生“重大变化”，“显着影响”其安全性或有效性，或引入新的风险，则不适合包含在PCCP中。。

The guidance also provides three examples of specific devices and modifications that would and would not be appropriate for inclusion in a PCCP. One example concerns a microarray-based IVD cancer predisposition risk assessment system for over-the-counter use intended to detect five single-nucleotide variants in BRCA1 and three SNVs in BRCA2 in saliva to describe if a person is at increased risk of breast cancer, ovarian cancer, or prostate cancer..

该指南还提供了三个特定设备和修改的例子，这些设备和修改不适合也不适合包含在PCCP中。一个例子涉及基于微阵列的非处方IVD癌症易感性风险评估系统，该系统旨在检测唾液中BRCA1中的五个单核苷酸变异和BRCA2中的三个SNV，以描述一个人是否患乳腺癌，卵巢癌或前列腺癌的风险增加。。

Examples of appropriate modifications include addition of new SNVs, addition of insertion and deletion variants up to 20 base pairs, and labeling updates to provide information on potentially cross-reactive polymorphisms. Inappropriate modifications include adding new copy number variants, new genes, changing the collection device and sample type, and moving from a manual to an automated process..

适当修改的例子包括添加新的SNV，添加多达20个碱基对的插入和缺失变体，以及标记更新以提供有关潜在交叉反应多态性的信息。不适当的修改包括添加新的拷贝数变体，新基因，更改采集设备和样品类型，以及从手动过程转向自动过程。。

In addition to providing details on what kinds of modifications may be included in a PCCP, the draft guidance lays out processes for establishing and writing PCCPs as well as for implementing modifications based on authorized PCCPs.

除了提供PCCP中可能包含的修改类型的详细信息外，指南草案还列出了建立和编写PCCP以及根据授权PCCP实施修改的流程。

The draft guidance will be open for public comment for 90 days following its official issuance on Aug. 22.

该指南草案将于8月22日正式发布后90天内公开征求公众意见。