UDI Compliance: What Does a Medical Device Manufacturer Do With Devices Already Distributed?

The FDA’s UDI Final Rule is not retroactive, meaning it does not apply to devices that were distributed before the compliance deadline.  However, existing inventory (at manufacturing site, distribution center or on consignment) needs to be sold or comply with the UDI Final Rule by September 24, 2017.

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.