Is It Recommended or Required to Register for ISBT 128 for a Device with Human Cells, Tissues, and Cellular Tissue-Base Product (HTC/P)?

It is not a requirement; it is a recommendation. There are many advantages for using ISBT 128 for HTC/P, the most important of which is the distinct identifier that identifies all tissues from a given donor. This unique identifier allows rapid recall of products should a problem with the donor be discovered after distribution of products.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.