FDA, skin tone and pulse oximeter

New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make these devices more reliable and less biased.
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with diverse skin tones.
FDA recommends more robust testing of pulse oximeters to avoid bias in people with dark skin tone
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the devices.
FDA recommends fixing racial disparities in pulse oximeter readings
The agency is calling for the devices to be tested on significantly more people, as well those with darker skin tones, steps experts say are critical to incentivizing manufacturers to fix racial disparities in the accuracy of the devices’ readings.
FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Responding to complaints that pulse oximeters that measure blood oxygen levels are less accurate in people with darker skin tones, the Food and Drug Administration Monday released long-awaited guidance proposing how manufacturers should test and label these devices.

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