Pulse oximeters are critical devices that estimate blood oxygen levels by shining red and infrared light through the skin. These readings guide treatment decisions in hospitals and clinics. However, studies have shown that these devices can be less accurate in individuals with darker skin tones, potentially delaying detection of conditions like hypoxemia.
In January 2025, the FDA released draft guidance titled Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations. This guidance proposes changes for device makers to ensure pulse oximeters perform accurately across a wide range of skin pigmentations.
Key proposed changes include:
- Larger, More Diverse Clinical Studies
Manufacturers are expected to evaluate their devices on a study population of 150 or more participants—a substantial increase from previous guidance, which required only about 10 participants. At least 25% of participants must have darker skin to better identify performance discrepancies across skin tones. JAMA Network+14AP News+14U.S. Food and Drug Administration+14Reuters+4U.S. Food and Drug Administration+4Regulations.gov+4tctmd.com - Standardized Skin Tone Assessment
Rather than relying on subjective or vague classifications like “dark” or “light,” device makers must use both the Monk Skin Tone (MST) scale—a visually assessed 10-point scale—and the Individual Typology Angle (ITA)—a spectrophotometric measure of pigmentation. This ensures consistent and objective reporting. Regulations.gov+6Viatom+6STAT+6 - Labeling for Performance Consistency
If testing shows that a device performs equally well across skin tones, manufacturers can submit updated labeling that states the device has been “evaluated to perform comparably” across diverse populations. This helps clinicians and patients make informed choices. arXiv+15U.S. Food and Drug Administration+15AP News+15
These updates reflect growing awareness of how design bias in medical technology can result in health disparities. Recent research indicates a higher risk of undetected low oxygen levels (occult hypoxemia) in people with darker pigmentation, making these enhancements especially meaningful.
What This Means for Patients and Providers
Patients—and especially those in communities of color—can expect more reliable oxygen monitoring as manufacturers adopt these guidelines. For healthcare providers, clarity in labeling and equitable device performance increases confidence in clinical decisions for all patients.
What It Means for Manufacturers
Device developers will need to:
- Adjust clinical study protocols to include larger, more diverse participant groups.
- Incorporate objective skin tone assessments into validation testing.
- Evaluate whether existing products meet the updated performance criteria; if so, they may update labelling without changing hardware or software.
- Engage in the FDA’s comment process as the guidance is still in draft form.
EMMA International’s Perspective
At EMMA International, we support medical device companies in adapting to evolving regulatory requirements. With this latest draft guidance, we stand ready to assist organizations in designing inclusive clinical validation strategies, managing regulatory submissions, and aligning labeling with equity-centered performance data. Proactively integrating these recommendations into development processes helps ensure both compliance and patient trust, strengthening device credibility and access.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
FDA. (2025, January 6). FDA proposes updated recommendations to help improve performance of pulse oximeters across skin tones [Press release]. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-proposes-updated-recommendations-help-improve-performance-pulse-oximeters-across-skin-tones
Associated Press. (2025, January 6). Pulse oximeters may misread oxygen levels in people of color. AP News. https://apnews.com/article/d5fde9b81251ac9d4e39c11264638909
