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FDA Response Letter to AdvaMed’s UDI Cross Reference Proposal

photo of an inventory control sheet

The Food and Drug Administration (FDA) sent this letter in response to issues AdvaMed raised to the FDA regarding implementation of the Unique Device Identification final rule (UDI rule). The objective of the UDI rule is to establish a system for the adequate identification of medical devices through distribution and use. For certain devices, FDA realizes there are unique complexities and challenges for conveying UDIs at the point of use for devices distributed in trays (e.g., spine, trauma and maxillofacial devices).