Some Human Cellular Tissue Products (HCTP) are considered “devices” and will require their assigned Unique Device Identifiers (UDI) to be tracked within the patient’s Electronic Health Record (EHR) and shared across the healthcare spectrum. Supply chain should be having interdepartmental conversations to determine how they will handle these types of products and their UDIs.
In September 2019, FDA announced its
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The Unique Device Identifier (UDI) is comprised of 2 segments: