The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can be less accurate for people with darker skin pigmentation than people with lighter pigmentation.
The agency outlined what information it would like to see in premarket submissions for medical pulse oximeters, including validation of the devices’ accuracy and ensuring the devices are tested across the range of skin pigmentations. The FDA also set out labeling recommendations, noting that devices should include a prominent statement if the device has been demonstrated to perform comparably across people with diverse skin pigmentations…
