NCHR urges FDA to require more diversity in trials to improve accuracy of pulse ox devices

December 2, 2022: NCHR testified at an FDA meeting that there is strong evidence that commonly-used pulse oximeters are less reliable for patients with pigmented skin. The FDA’s current guidelines do not require product labeling to address the impact of skin pigmentation on pulse oximetry. While labeling is important to alert users to possible inaccuracies, it does not diminish the importance of developing devices that are effective for everyone.

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