FDA Proposes Guidance to Improve Pulse Oximeter Accuracy Across Skin Tones

The FDA has issued draft guidance aimed at improving the accuracy and performance of pulse oximeters used in medical settings, particularly across different skin tones. Current evidence suggests that pulse oximeters may perform less accurately in individuals with darker skin pigmentation, prompting the need for updated recommendations to address this disparity.

The proposed guidance provides manufacturers with detailed recommendations on gathering clinical data to evaluate device accuracy across diverse skin tones. Key elements include increasing the number of study participants, using standardized methods for assessing skin tone, and labeling devices that demonstrate comparable performance across populations. The FDA also plans to create a publicly available webpage listing pulse oximeters that meet these updated criteria.

“This draft guidance is aligned with the FDA’s broader commitment to helping facilitate the development of high-quality, safe, and effective medical devices,” said Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, in a press release.

The guidance applies to pulse oximeters intended for medical purposes, primarily used in hospitals and clinical settings, and does not apply to general wellness or consumer-grade devices. Comments on the draft guidance are open for 60 days, after which the FDA will review feedback and finalize the recommendations.

Reference

FDA proposes updated recommendations to help improve performance of pulse oximeters across skin tones. US Food and Drug Administration. January 6, 2025. Accessed January 16, 2025. https://www.fda.gov/news-events/press-announcements/fda-proposes-updated-recommendations-help-improve-performance-pulse-oximeters-across-skin-tones