UDI Compliance: Impact on Medical Device Warehouse Operations

In September 2013, the FDA released their final ruling on the Unique Device Identification (UDI) regulation mandating that all medical device manufacturers standardize labeling, include report device attributes for a publically available database, and apply a permanent identification on devices intended to be reused. To ensure UDI compliance, medical device manufacturers of all sizes must undertake a concerted effort and apply a defined strategy to achieve UDI compliance. 

Various areas of a medical device company are impacted by UDI compliance requirements; however, the effect on warehouse and distribution operations is often not considered. Securing a strong understanding of the UDI regulation, developing a sustainable compliance program, and implementing the necessary measures will help avoid significant supply chain costs. These costs may include accelerated label rework, excess or unusable inventory and incremental labor associated with product handling. Following a brief summary of the UDI regulation and its requirements, this paper will highlight UDI’s impact on warehouse and distribution. 

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