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.
There will also be a discussion on the FDA guidance Recognition List Number: 026 and what are the current FDA expectations with this testing.
Presenter: Thor Rollins