Is UDI’s Assumed Application to Class III Medical Devices Connected with Serialization Initiatives?

At this point, there are no serialization or track and trace mandates in the United States that apply to medical devices. There are a number of activities in the pharmaceutical space for drug track and trace, specifically FDA’s Drug Supply Chain Security Act (DSCSA) legislation that requires eventual serialization of pharmaceutical products. There is nothing like this in the realm of medical devices.

Currently, UDI is solely concerned with medical device identification and its associated metadata. All stakeholders throughout the life cycle of the device should utilize UDI, but there is no mandate to either serialize or manage the traceability of the device the way there is within the pharmaceutical space.  If, in the future, serialization initiatives move into the medical device space, UDI could support this.

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.