As For Implantable Medical Devices Which Are Degradable And Absorbable, Can Published Literature By Research Institutions Related To The Products Made Of The Same Material Or The Raw Material Of The Product Under Application Be Used As The Performance Research Data On Product Degradation?

As for implantable medical devices which are degradable and absorbable, if relevant published literature by research institutions is intended to be used as the performance research data on product degradation, the difference between the products or materials in the literature and the product under application should be analyzed to determine its effect on the evaluation result of degradation performance. Generally, a degradation study includes studies of degradation products and degradation period. For a study on degradation period, if the published literature is not related to the product under application, it will have limited value for reference, because the degradation period of products is correlated with the performance parameters (e.g. molecular weight, distribution of molecular weight, crystallinity and etc. of a polymer) and the manufacturing process of the component materials of products. In this case, administrative counterparts are recommended to conduct experimental studies on degradation period of the product under application. For metabolism studies on degradation products, if the degradation products for the devices or raw materials in the literature are the same with those of the product under application, then the research data in literature on metabolism of degradation products can be referred. And the administrative counterpart may submit the related literature and analyze the effects of different implantation sites (if involved) on research data.