FDA Issues Final Rule on UDI

Elizabeth Fassbender

On Sept. 20, 2013, the U.S. Food and Drug Administration (FDA) released the much-anticipated final rule on a Unique Device Identifier (UDI) system. The FDA has worked for 10 years to develop the system and database to track medical devices, and the final rule was well-received by patient groups, providers, and industry as an important step to enhance patient safety.

One of the biggest changes in the final rule was the removal of the requirement for all implantable devices to have the UDI marked directly on the device. The original proposal required manufacturers to directly mark a UDI on three device types: those implanted in the body for more than 30 days, those intended to be used more than once, and stand-alone software.

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