UDI

Medical device labeling guidelines have been updated by the U.S. Food and Drug Administration (FDA) with the aim of clarifying the ways in which medical devices may be labeled in order to prevent confusion for caregivers, patients and medical staff. The FDA’s final rule has established a system for the unique identification of medical devices

Unique Device Identification (UDI) refers to a system that is designed to mark the labels of medical devices used within the healthcare system. The U.S. FDA released a final ruling on the system in 2014. The system is intended to be fully implemented over the next several years.

The U.S. Federal Drug Administration (FDA) classifies medical devices. There are three main classifications Class I, Class II, and Class III. The assignment of a classification for a device depends upon the level of risk that is associated with the device.

The U.S. Food and Drug Administration (FDA) released the final rule on a Unique Device Identifier (UDI) system on September 20, 2013. The system, along with the Global Unique Device Identification Database (GUDID) was 10 years in the making and is a vital step toward increasing the safety of medical devices. One of the most