FDA 有权命令某些医疗器械的制造商建立和维护跟踪其器械的系统 (21 CFR 821)。这是为了确保制造商可以在必要时*将设备从市场上撤下，并通知患者和提供者设备的任何重大问题。 

对于其故障很可能造成严重和不利健康后果的设备，需要进行医疗设备跟踪；拟植入人体一年以上；或者是在设备用户设施之外使用的生命维持或生命支持设备。

FDA Fact Sheets: Unique Device Identification (UDI) To more effectively identify medical devices through their distribution and use, FDA requires devices be identified with a unique device identification (UDI) number. A UDI is a unique numeric or alphanumeric code that is part of a device's labeling and includes a device identifier, which is specific to a device model, and a production identifier, which includes the production information for that specific device (lot, serial number or expiration date). Another component of the UDI system is an FDA-controlled database that includes a standard set of identifying elements for each UDI. This information is publicly available so that users of a medical device can easily look up the information.
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