Pulse oximeters overestimate arterial oxygen saturation and provide more variable readings in people with darker skin pigmentations—risking clinically significant undetected hypoxemia.1 To reduce this difference in performance of pulse oximetry, the US Food and Drug Administration (FDA) suggested in 2013 that manufacturers include participants “with a range of skin pigmentations” in their testing.2 At that time, the Fitzpatrick scale was often used to quantify skin tone, but this scale has been criticized for being subjective and susceptible to interoperator variability.3 The response to the 2013 voluntary guidance has not been evaluated to inform revised pulse oximetry guidance under development since 2022.4

Ferryman K, Crews DC, Drabo EF, Iwashyna TJ, Kane O, Jackson JW. Adherence to FDA Guidance on Pulse Oximetry Testing Among Diverse Individuals, 1996-2024. JAMA. 2025;333(7):631–632. doi:10.1001/jama.2024.26473