The biocompatibility assessment of a device is a small yet critical component for a device submission to any global market. Biocompatibility is evidence that the materials and processes used to manufacture the device are compatible with the intended patient contact. Evaluating biocompatibility consists of three main parts: a biological evaluation plan (BEP), testing/risk assessment, and a biological evaluation report (BER). We will focus on the key components for each of these parts and present case studies for context. Important information for medical device manufacturers that will be presented include:

• How to fulfill the physical/chemical information requirement
• Understanding when justifications are appropriate
• Important considerations when submitting samples for testing
• How to address failed tests