The U.S. Food and Drug Administration (FDA) issued final guidance for clarity on the definition of “remanufacturing” for reusable medical devices that need maintenance or repair.

美国食品和药物管理局（FDA）发布了最终指南，以明确需要维护或维修的可重复使用医疗器械的“再制造”定义。

The guidance aims to ensure consistency about what constitutes remanufacturing activities and promote more understanding of federal law and regulations around remanufacturing. The guidance was released due to extensive postmarket review and public comments that highlighted the need for clarity due to different regulatory implications between medical device “servicing” and “remanufacturing.”.

该指南旨在确保再制造活动构成的一致性，并促进对再制造相关联邦法律法规的更多理解。该指南的发布是由于广泛的上市后审查和公众评论，这些评论强调了由于医疗器械“维修”和“再制造”之间的监管含义不同而需要明确。

By the FDA’s definition, remanufacturing is the “processing, conditioning, renovating, repackaging, restoring or any other act done to a finished device that significantly changes the finished device’s performance, safety specifications or intended use. Servicing is the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use.”.

根据FDA的定义，再制造是“对成品设备进行加工、调理、翻新、重新包装、恢复或任何其他行为，这些行为会显着改变成品设备的性能、安全规范或预期用途。维修是指在分发后对成品设备中的一个或多个部件进行维修和/或预防性或常规维护，以使其恢复原始设备制造商（OEM）制定的安全和性能规范，并满足其原始预期用途。”。

Remanufacturing, according to the agency, is simply when a major alteration is made to a device’s performance, safety specifications, or intended use—changing from what was legally marketed or approved, cleared, or authorized by the FDA.

根据该机构的说法，再制造只是对设备的性能、安全规格或预期用途进行重大更改，而不是合法销售或FDA批准、批准或授权的产品。

The agency also defined third-party servicers as “entities, other than the manufacturer or healthcare delivery organizations using the device, that maintain, restore, refurbish, repair or service a finished device after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use.”.

该机构还将第三方服务商定义为“使用该设备的制造商或医疗保健服务机构以外的实体，这些实体在分发后对成品设备进行维护、恢复、翻新、维修或服务，以使其恢复OEM制定的安全和性能规范，并满足其原始预期用途。”。

The guidance also recommend specific information be including in reusable device labeling about preventive maintenance and repair. This includes instructions for adequately returning a device to OEM-established performance and safety specifications.

该指南还建议在可重复使用设备标签中包含有关预防性维护和维修的具体信息。这包括将设备充分返回OEM制定的性能和安全规范的说明。

The FDA affirmed that labeling recommendations don’t encourage disclosure of trade secrets or confidential commercial information and that regulations or policies shouldn’t be an impediment to sharing information, tools, and access to third-party servicers.

FDA确认，标签建议不鼓励披露商业秘密或机密商业信息，法规或政策不应妨碍共享信息、工具和与第三方服务商的接触。

“Today’s action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices,” said Jeff Shuren, MD, J.D., director of the FDA’s Center for Devices and Radiological Health. “This guidance provides important clarity on defining remanufacturing and helps to remove perceived barriers to obtaining repair or maintenance of a device if it does not alter the safety, performance, or intended use.”.

FDA设备与放射健康中心主任Jeff Shuren医学博士说：“今天的行动是我们确保患者继续获得高质量，安全和有效医疗设备的使命向前迈出的重要一步。”。“本指南为定义再制造提供了重要的明确性，并有助于消除在不改变安全性、性能或预期用途的情况下对设备进行维修或维护的障碍。”。

The FDA’s final guidance document can be viewed here.

FDA的最终指导文件可以在这里查看。