The FDA's UDI Initiative – A Definitive Guide
It’s no surprise the medical device industry has been struggling with recalls for a number of years due to labeling errors. Did you know that during the period of 2003 to 2012 there was a 97% increase in medical device recalls?
And, of those recalls, over 67% were due to human labeling errors for Class I, Class II and Class III FDA device classifications? The FDA’s unique device identifier (UDI) mandate promises to trace and track medical devices and reduce mislabeling – whether or not you are heading for 510(k) clearance or adhering to 21 CFR 211 best practices.
Are you ready to comply with the FDA’s UDI mandate for medical device labeling?
Download our UDI infographic to get a clear picture of UDI and its benefits, the timescales involved with the FDA mandate and some tips on moving ahead with your UDI implementation.