Derivation of evidence-based oral-to-parenteral uncertainty factors for medical device toxicological risk assessment.

Bryant Moeller¹

¹ResMed Inc., 9001 Spectrum Center Blvd, San Diego, CA, 92123, USA. Electronic address: Bryant.moeller@resmed.com.

Abstract

Uncertainty factors (UFs) are used in toxicological risk assessment to address uncertainty when extrapolating from available data to intended exposure scenarios. In medical device biocompatibility evaluation, oral toxicity data are frequently extrapolated to parenteral exposures, for which ISO 10993-17 specifies a default oral-to-parenteral UF of 10. Although the standard permits lower values when…

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