Does the UDI Extension for Some Implantable Devices Apply to All UDI Requirements?

The extension for some implantable devices does not apply to all Unique Device Identification (UDI) requirements.  The extension only applies to the label requirement.  Requirements to collect, store, normalize, validate and submit data to the Global UDI database (GUDID) must be met by September 24, 2015.

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.