医疗器械临床验证是指通过临床使用来验证该医疗器械与已上市产品的主要结构、性能等要素是否实质性等同，是否具有同样的安全性、有效性。
Clinical verification refers to verifying the testing products and the products already in the market are virtually the same in terms of the basic structure, performance, safety and effectiveness.
该中心在确保新上市的医疗器械的安全和有效。
The Center in ensuring that new medical devices listed on the safe and effective.
FDA希望，在不良事件报告、上市后分析、器械召回和库存文档管理的情况下，该系统能够更加有效和准确地识别器械。
The FDA hopes this will lead to more efficient and accurate identifying of devices in the case of adverse event reporting, post-market analysis, managing device recalls and inventory documentation.
明确FDA对已批准上市的医疗器械在其产品概述及标签上注明年龄、人种及特定种族信息的期望。
To specify FDA's expectations for reporting age, race, and ethnicity-specific information in summaries and labeling of approved devices.
医疗器械不良事件监测是确保上市医疗器械安全有效的重要手段之一。
Medical device adverse event monitoring is one of the most important methods to guarantee the safety of post-marketing products.
这些资金来源依赖于负责开发医疗器械上市后监测系统框架的规划委员会的建议。
The funding is tied to recommendations from the planning board tasked with developing the postmarket medical device surveillance system framework.
这些资金来源依赖于负责开发医疗器械上市后监测系统框架的规划委员会的建议。
The funding is tied to recommendations from the planning board tasked with developing the postmarket medical device surveillance system framework.
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