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Regulatory Science Tools Catalog

Biocompatibility and Toxicology
This regulatory science tool is a method that applies the ISO 10993-17 toxicological risk assessment approach to medical device extractables screening data to assess systemic toxicity, genotoxicity, carcinogenicity, or reproductive/developmental toxicity in the biocompatibility evaluation of a medical device.
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A tool to determine the extractables profile of additive-manufactured orthopedic casts produced by fused filament fabrication method
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Conduct screening level risk assessments to aid in the biocompatibility evaluation of bulk additives and impurities in polymeric medical device components
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Predicts the impact of extraction conditions, sample geometry and material properties on extraction test efficiency