Does the UDI Extension for Some Implantable Devices Apply to All Class II (FDASIA) Devices?

The extension for some implantable devices does not apply to all class II (FDASIA) medical devices.  The extension only applies to devices that are classified as FDASIA implants and distributed non-sterile.  It’s a limited subset of all FDASIA devices that have been granted this label extension to 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.