This whitepaper highlights the basics of the UDI system that everyone should know, including FDA’s current guidance and interpretations on implementing the rule. When the due date rolls around for your device, will you be ready? If you have already started implementing UDI, are you missing anything else?
Are you ready for September 24, 2015? In just over a month, several categories of Class I and II devices will reach their compliance due date for labeling requirements under the Unique Device Identification (“UDI”) regulations. For companies with implantable, life-supporting and life-sustaining devices, FDA has granted a one-month extension to submit device information to the Global Unique Device Identification Database (“GUDID) (October 24, 2015). These compliance dates are the second phase of UDI implementation which started in 2014 with Class III devices. The UDI system implementation will continue until September 24, 2020, at which time all devices should be compliant with the UDI regulations.
Failure to comply with the UDI rule is not an option for almost all medical device companies. The UDI regulations contain many requirements, exceptions and nuances, so a proactive approach of understanding what you need to know about UDI will help you achieve compliance when you need it.