-
hzy2 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 6 years, 6 months ago
If a new product is getting ready to be put into the market, there are a lot of testing that needs to be done in order to prove to FDA that it is biocompatible. The ISO10933 table provides a series of tests that can be used to test devices based on which category they fall under. For example, if you developed a patch that will only come in contact with the skin for a limited amount of time, you can avoid most of the biocompatibility testing listed on the table and stick to the cytotoxicity, sensitization and irritation of intracutaneous reactivity tests only. However, if you have a device that will be implanted inside the body for a prolonged time, then you will have to do extra testing including genotoxicity and hemocompatibility.