FDA takes steps to reduce pulse oximeter disparities

The Food and Drug Administration this week released a discussion paper on improving the accuracy of pulse oximeter devices for people with darker skin pigmentation. The discussion paper offers a pathway to improve the quality of premarket studies and associated methods used to evaluate pulse oximeter performance that takes into account skin pigmentation and patient-reported race and ethnicity. The FDA will use the feedback from the paper to inform an advisory committee virtual meeting on the topic on Feb. 2, 2024, as well as to discuss the type and amount of data manufacturers should provide to the agency to evaluate pulse oximeter performance. Comments are due by Jan. 16, 2024. (FDA news release, 11/16/23)