Coverage

Examination of UDI Implementation and Lessons for Manufacturers of Class II Devices

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.

 READ THE FULL ARTICLE HERE