Basics of Biocompatibility: Information Needed for Assessment by the FDA

Official primary resource: www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/basics-biocompatibility-information-needed-assessment-fda . Locators: How the FDA Assesses or Evaluates Biocompatibility, concerning final finished form, processing and residuals; Biocompatibility Factors of Interest to the FDA, concerning nature, type, frequency and duration of contact. Companion endpoint tables: www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/biocompatibility-evaluation-endpoints-device-category . These are evaluation principles, not a universal requirement to perform every listed test.