FDA releases draft guidance on Unique Device Identification System

The Food and Drug Administration issued draft guidance regarding the form and content that should be included within unique device identifiers (UDI) for medical devices.

The UDI rule is intended to create a standardized identification system for medical devices used in the United States. This will make it possible to rapidly and definitively identify a device and some key attributes that affect its safe and effective use. The UDI rule requires that the label and device packages of every medical device distributed in the United States bear a UDI, unless an exception or alternative applies.