Exceptions to the UDI Compliance Deadline

Medical device manufacturers can ask the FDA for an exception to the UDI compliance deadline.  Several medical device manufacturers have asked for and received an exception because of compliance difficulties.  Any exception to the UDI deadline requires the medical device company to have a compliance plan and date of when the company plans to be UDI compliant.

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.