UDI Compliance: How Does the Single Use Device Packaging Exception Work?

A single use device is not required to have a UDI on the package if it meets the following criteria:

• Device is distributed inside a package with more of the same devices. (The package that contains multiple single use devices is required to have a UDI.)
• Device is intended to be stored in the package with more of the same products until use
• Device is not intended for distribution
• Device is not considered an implant by the FDA (Check this list to see if the FDA considers your device an implant.)

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.