Direct Marking for FDA UDI Compliance

Direct marking is an important component of the FDA Unique Device Identification (UDI) regulation. The purpose of UDI is to establish a standard method for identifying and tracing medical devices throughout their lifecycles, from production, to distribution, to use.

For medical devices that are reused many times during their lifecycles, a UDI must be able to withstand any amount of handling or reprocessing.

The most reliable way to ensure a UDI lasts the lifecycle of a multi-use device is by affixing a permanent mark to the device itself, rather than a temporary package or label.

Direct part marking (DPM) is not a new concept in industrial manufacturing, but is relatively new territory for medical device identification.

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