When Abnormal Results Are Present In The Study On Chemical Performance Of Non-active Medical Device Products, How To Make Evaluation?

When abnormal results are present in the study on chemical performance of non-active medical device products, it is recommended to evaluate the cause of the abnormal results and comprehensively evaluate the safety of the medical device. For example, for the coated catheter products, if the coating material causes abnormal test results of reducing substances, it is recommended to test the intermediate products of the product before coating to confirm whether the chemical performance test result is interfered by the coating. Meanwhile, the clinical application history and biocompatibility data of the coating material should be combined to comprehensive evaluate product safety.