Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work for patients of color, under a new federal proposal released Monday.

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.

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin

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.