Calculation of Duration of Exposure & Associated Biological Effects for Biocompatibility Evaluation

In the biocompatibility assessment of medical devices, two of the primary points of consideration are how long a device contacts the body and what type of tissue is contacted. Recently, FDA and the upcoming ISO 10993-1 revision have changed the paradigm of how the duration of exposure a device has with the body is calculated. Correlated with the change, many devices which are absorbable, repeat use or have known bioaccumulating leachable compounds may be reclassified to have longer durations of exposure than they did previously, and the associated biological effects will be detailed. Key Learning Points: 1. Learn how to calculate the exposure of medical devices to the body 2. What are the current, expanded regulatory requirements surrounding absorbable and repeat use devices 3. How do these changes affect your biocompatibility assessments and timelines going forward