For Medical Devices Made Of Biological Tissue Materials Such As Animal-derived Or Allogenic Tissues Through The Decellularization Process, Which Item Requirements Related To Quality Control Of Immunogenicity Should Be Considered At Least?

It is recommended that the administrative counterpart analyze the substances that may cause human immune response, such as DNA, RNA, a-Gal antigen, phospholipids, heteroproteins, and polysaccharides, possibly present in the final product from the sources of product materials, immunogenicity control technology, and product performance. When appropriate, representative substances may be selected for qualitative and quantitative testing, and its residual control can be used as one of the requirements for quality control of product immunogenicity.