The preclinical biocompatibility evaluation of medical devices involves extracting the device with various polar and nonpolar solvents, and then use of these solvents in biocompatibility tests to assess whether the extract produces adverse biological effects.  An alternate approach based on chemical characterization of the extracts and toxicological risk assessment of the extractable compounds is gaining increased acceptance in regulatory agencies.  During this talk, the application of this alternative approach will be presented, such as: how analytical chemistry and toxicological risk assessment techniques can be used to assess medical device biocompatibility (<i>e.g.</i>, extractable & leachable testing and computational exposure modeling), when this alternative approach can be used as part of the preclinical biocompatibility assessment of medical devices, as well as, challenges associated with practical implementation of this alternative approach.<br/>

Chemical characterization and toxicological risk assessment of medical devices

254th National Meeting (2017)

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