Introduction to the UDI system in the USA

 

The FDA established a unique device identification system to identify medical devices through their distribution and use. It affects all medical device manufacturers and is being introduced in phases to allow time to change labeling, packaging, and internal documentation. In this video we’ll describe some of the key aspects of UDI, examine why it is necessary, and take a look at the benefits the program provides. We’ll also give you a good idea of what to expect as far as manufacture requirements go such as labeling and packaging.