FDA Proposes New Guidelines for Pulse Oximeters' Accuracy Across Skin Tones

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The U.S. Food and Drug Administration (FDA) has released a draft guidance requiring pulse oximeter manufacturers to gather extensive clinical data to demonstrate their devices work accurately across a diverse range of skin tones.

This long-awaited guidance addresses growing concerns that pulse oximeters, which are used to quickly estimate blood oxygen levels, tend to be less reliable for individuals with darker skin tones.

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The FDA is recommending that manufacturers test their devices on at least 150 participants, with a balanced representation of light, medium, and dark skin tones. Notably, half of the participants in the dark skin category should have very dark skin. Additionally, the FDA advises companies to assess skin pigmentation using both subjective visual evaluation and scientifically-based measurements.

This draft guidance marks a significant step in addressing the racial disparities in the accuracy of pulse oximeters. The FDA is accepting public comments for 60 days before finalizing the guidance.

Pulse oximeters work by sending two wavelengths of light into the skin to estimate oxygen levels in the blood, based on how much light is absorbed. These devices became vital in emergency care during the COVID-19 pandemic. However, research dating back several decades has highlighted the device’s limitations for people with darker skin, as melanin absorbs light, reducing the amount that passes through. Newer studies have shown that this can lead to the overestimation of oxygen levels in Black patients, potentially causing delays in treatment and increasing the risk of severe outcomes, particularly during the COVID-19 crisis.

In 2021, the FDA issued a safety warning to doctors and the public about the device’s inaccuracies, underscoring the need for improved accuracy across all patient demographics.

While the draft guidance is not legally binding, it applies only to pulse oximeters used in medical settings such as hospitals. The FDA does not regulate over-the-counter devices, which are widely available for personal use.

The move aims to ensure pulse oximeters provide reliable results for everyone, helping to reduce health disparities and improve patient care.