FDA releases guidance to improve pulse oximeter accuracy

The Food and Drug Administration published long-awaited draft guidance to improve pulse oximeter accuracy and performance across a range of skin colors. The common devices can give less accurate readings for people with darker skin tones, which can result in adverse outcomes. The draft guidance contains recommendations for manufacturers on how to gather clinical data to help improve the clinical study design and validation efforts to pulse oximeters to evaluate their performance across the range of skin colors. Comments on the guidance are due by March 7. Separately, a research letter published in JAMA Network Open found “low but improving uptake” of reporting about the diversity of participants in summary documents for FDA-cleared pulse oximeters following the issuance of voluntary guidance in 2013. (FDA news release, 1/6/25)