FDA Updates Guidance on Pulse ox Devices Used in Healthcare

The U.S. Food and Drug Administration is seeking public comment on new recommendations for nonclinical and clinical performance testing to support premarket submissions for pulse oximeters for medical purposes. These include devices with a function that estimates the amount of oxygen in arterial blood and pulse rate.In 2023, the FDA issued a warning about potential risks of inaccuracy under certain circumstances and said it became aware that pulse oximeters could be less accurate in people with dark skin pigmentation. The agency then scheduled public meetings last year to reassess its existing pulse oximetry guidance. The new proposed update, posted on its website, sharpens recommendations for gathering real-world and laboratory clinical data to evaluate device performance accuracy across the range of skin pigmentations, using both subjective and objective methods to standardize evaluations of pulse oximeter products used in healthcare delivery.