First, I would go over the manual that came with the new biomaterial and research about it, discover the chemical name, the formulation data/report, the manufacturing info, the sterilization compatibility, etc. and inquire the manufacturer if there is any unclear info. Depending on the biomaterial and the medical device category, further checks would be applied. As many above replies mentioned, I will follow the ISO 10993 recommendation, the biological evaluation of medical devices, and apply it to my product specifications and device modifications. In order to avoid any toxicity risk, both the medical device and the new biomaterial should be studied. It is important to know whether the device would have a direct contact to Human tissue or not (in case of contacting body, knowing the duration of contact is essential). Also, I would determine whether this biomaterial would be used with a surface device (ex. mucosal membrane), an external communicating device (ex. blood path, tissue/bone/dentin), or with an implant device (tissue, blood, bone).
– A detailed evaluation of any possible biocompatibility risk should involve assessing physical characteristics (ex. mechanical, thermal, electromagnetic), that may affect the tissue negatively, in addition to the chemical toxicity testing.

(Ref. FDA.gov & Wikipedia)