How Do I Know if a Class II Device Needs to be UDI Compliant by September 2015 (FDASIA) or September 2016?

Medical devices classified as implantable, life-saving and life-sustaining by the FDA must be UDI compliant by September 24, 2015.  The FDA lists every medical device by product code that must be UDI compliant in 2015 on this list.  If the class II medical device is not on the list, it does not need to be compliant until September 24, 2016.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.