The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.

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.

Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use both the newly developed Monk Skin Tone scale and another scale, called the individual typology angle (ITA), which is based on spectrophotometric measurements.

The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with diverse skin tones.

The U.S. Food and Drug Administration proposed new guidance for devices used to monitor blood oxygen levels to improve their accuracy and performance across a range of skin tones.