How the GUDID was it for you?
An examination of UDI implementation and lessons for manufacturers of Class II device
Almost two and a half years after the FDA issued its final rule on a Unique Device Identification system, the clock is ticking relentlessly towards the next critical deadline in the timetable for its compulsory introduction.
By September 2016, the labels and packages of all Class II medical devices must bear a Unique Device Identifier (UDI) – and data for such devices must be submitted to the FDA’s Global Unique Device Identification Database (GUDID).
The implications for medical device companies are significant. Assuring UDI compliance requires a major review not only of an organization’s labeling capabilities but also how it connects with all the other divisions that impact supply chain operations.
This Whitepaper examines the experiences of those organizations that have made the transition and outlines the lessons that companies facing the imminent deadline can learn from them.