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. Furthermore, the journey towards UDI compliance requires an enterprise-wide program of change management to ensure the requisite infrastructure is in place. It’s a journey that manufacturers of Class III and implantable, life-supporting and life-sustaining devices have already made – and for many, it has proved to be a challenging one.