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The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or to be used more than once by multiple patients to be marked with a permanent Unique Device Identifier (UDI). This is known as UDI direct marking.
The UDI system seeks to improve the identification of medical devices by making it possible to rapidly and definitively identify a device and certain key attributes that affect its safe and effective use.
The FDA does not specify any particular approach to directly mark devices. The labeler should determine the appropriate method to provide such a marking on the device itself.
The most reliable way to ensure a UDI lasts for the life of a multi-use device is by marking the device itself with permanent a mark, rather than a temporary package or label, which can be discarded, torn, obscured, wiped off, or easily degraded.
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