The Nelson Laboratories Innovation Brief at MDM East 2012 will cover recent FDA trends impacting in vitro hemocompatibility and genotoxicity testing. This presentation will discuss the latest points from the ISO committee members on ISO 10993-3 and ISO 10993-4, including:
- An overview of the testing in ISO 10993-4: Selection of tests for interactions with blood and ISO 10993-3:
- Tests for genotoxicity, carcinogenicity and reproductive toxicity, specifically the hemocompatibility and when to perform the direct and indirect methods.
- The complement activation test and why the FDA has been requiring this test and future considerations.
- The in vivo dog thrombosis and issues and solutions around this test method and an in-depth discussion on the changes that are proposed to the standards and those potential implications on future testing requirements.