AG Bonta to FDA: Better Pulse Oximeters Needed Now to Address Inaccuracies Impacting Communities of Color
Published Date: Mar 10, 2025
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AG Rob Bonta today announced submitting a comment letter to the U.S. Food and Drug Administration (FDA) urging the agency to immediately take steps to fulfill its promised actions to address inaccurate results in pulse oximeters based on race. On January 7, 2025, the FDA invited the public to provide comment on its draft guidance that, when finalized, will provide recommendations concerning non-clinical and clinical performance testing of pulse oximeters. Today’s letter responds to that invitation. Pulse oximeters are routinely used to measure blood oxygen levels, which inform medical care for a wide range of illnesses including heart failure, sleep apnea, and respiratory conditions. Researchers have known for decades that pulse oximeters often do not provide accurate results for darker skin tones. The COVID-19 pandemic led to a significant increase in evidence and wider awareness of the implications of these inaccurate results based on skin color.