Abstract

There is urgent need for recommendations on how to accurately characterize skin pigment for the purpose of ensuring diversity in medical-device research, development, and regulatory validation cohorts. We compared performance of multiple subjective and objective skin-pigment assessment methods in 789 participants. We found that common methods for skin-pigment characterization, such as race or subjective skin-color scales, have important limitations. When applied to the same cohort, different methods yield different proportions of light, medium, and dark subjects and may overestimate diversity of skin pigment. Previously published ITA thresholds for defining “dark” skin may be too light.