Biocompatibility for Medical Devices 101 – Prepare for Clinical Trial

This is a crash course overview of medical device biocompatibility. We will provide an overview of the guidance provided in ISO 10993-1 and FDA expectations for demonstration of biocompatibility leading up to a medical device clinical trial or 510(k) submission. Biocompatibility is discussed from the perspective of systemic vs non-systemic biological endpoints, with emphasis on test selection, sample preparation, chemistry testing, and toxicological evaluation. The “big 3” tests (cytotoxicity, sensitization, and irritation) are summarized followed by the fundamentals of medical device extractables testing and toxicological assessment. Attendees will learn: • Critical background info regarding biocompatibility evaluation in preparation for IDE or 510(k) submission • High-level overview of biocompatibility testing requirements • Role of chemistry and toxicological evaluation in medical device regulatory submissions