This is a crash course overview of medical device biocompatibility, designed to provide a comprehensive understanding of the key principles and practices in the field. We will provide an overview of the guidance provided in ISO 10993-1 and FDA expectations for demonstrating biocompatibility leading up to a medical device clinical trial or 510(k) submission. Biocompatibility is discussed from the perspective of systemic versus non-systemic biological endpoints, with an emphasis on test selection, sample preparation, chemistry testing, and toxicological evaluation.
The “big 3” tests (cytotoxicity, sensitization, and irritation) will be summarized, highlighting their importance in ensuring the safety of medical devices. The presentation will also cover the fundamentals of medical device extractables testing and toxicological assessment, providing a clear understanding of how to identify and evaluate potential risks associated with device materials. Viewers will learn about the critical aspects of preparing samples for testing, selecting appropriate tests, and interpreting results. By the end of this session, viewers will have a solid foundation in medical device biocompatibility, equipped with the knowledge to meet regulatory requirements and ensure the safety and efficacy of their products.