Every medical device needs to have proven biocompatibility to protect users from potential biological risks arising from its intended use. In particular, cytotoxicity must be evaluated for every medical device, regardless of its classification. Cytotoxicity testing is often conducted using an in vitro cell culture method because of its high sensitivity and low cost. However, in vitro cytotoxicity testing is very sensitive and can result in failures. A normal reaction to a failing cytotoxicity test result is often a feeling of panic. This is understandable as it may seem like the submission of the device is in jeopardy and that the product will not be approved for commercialization. This presentation will provide a step-by-step guide regarding how to investigate and assess in vitro cytotoxicity failures to determine appropriate solutions.

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