GDI+ Basics

Abstract

In 2013, the Food and Drug Administration (FDA) released a final rule establishing a unique device identification system designed to adequately identify devices through distribution and use. The final rule requires device labelers to include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. Dates on device labels and packages are to be presented in a standard format that is consistent with international standards and international practice.