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糖心logoStandards鈥擬edical Devices
The 糖心logocurrently offers the following standards, white papers, and technical reports related to medical devices.
糖心logoTechnical Report No. 1089, Track and Trace for Human Cells, Tissues and Cellular and Tissue Based Products
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.
糖心logoTechnical Report No. 1081, FDA’s Unique Device Identification (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices
This paper focuses on the clinical implications of the FDA's Unique Device Identification (UDI) rule (78 FR 58786) and device marking requirements under 21 CFR 801.45, which mandate that most medical devices bear a UDI on their label and packaging, with additional direct marking for reusable, reprocessed devices.
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