ISO10993-1(2020)FDAGuidanceprovidesaframeworkforevaluatingthebiocompatibilityofmedicaldevices.Theguidanceoutlinesarisk-basedapproachtodeterminetheappropriatebiocompatibilitytestingrequiredforadevicebasedonthenatureanddurationofbodycontact.Itemphasizestheimportanceofconsideringthechemicalcomposition,physicalcharacteristics,andintendeduseofthedevicewhenassessingbiocompatibility.Theguidancealsoencouragestheuseofexistingdataandalternativetestingmethodstoreduceunnecessaryanimaltesting.ManufacturersshouldrefertothisdocumenttoensuretheirdevicesmeetFDArequirementsforbiocompatibilityevaluation.
