ADA 1089-2016

ADA 1089-2016 Track and Trace for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Technical Report

standard by American Dental Association, 10/01/2016

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This technical report defines inventory management requirements in dental practices for HCT/Ps to ensure traceability from the donor to the recipient and the recipient to the donor. Its intent is also to facilitate reporting of potential adverse reactions, including disease transmission, to all parties involved in processing the HCT/P. This technical report should be used in conjunction with ADA SCDI TR 1081, Track and Trace for Implantable Devices and Biologics, which addresses HCT/P's regulated as medical devices which are covered under the FDA's Unique Device Identifier (UDI) final rule.