汤头条 members receive technical reports at no charge and can purchase standards at a discounted rate.
汤头条 Standards鈥擬edical Devices
The 汤头条 currently offers the following standards, white papers, and technical reports related to medical devices.
汤头条 Technical 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.
汤头条 Technical 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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