FDA Drafts New Recommendations for More Inclusive Pulse Oximeter Testing
By Physician’s Briefing Staff HealthDay Reporter
TUESDAY, Jan. 7, 2025 -- The U.S. Food and Drug Administration released draft guidelines on Jan. 6 proposing that manufacturers conduct larger, more inclusive studies to ensure pulse oximeters work for people with darker skin.
Among the key changes, the new recommendations call for enrolling at least 150 patients with diverse skin tones in clinical studies; increasing representation of patients with darker skin to at least 25 percent in each study, up from 15 percent; and using multiple methods to evaluate skin pigmentation, including scientific measurements of melanin.
The proposal applies only to professional pulse oximeters used in medical settings, such as hospitals and clinics. Over-the-counter oximeters, often marketed as "general wellness" devices, are not affected.
The FDA recommendations come after studies, including one from 2021, revealed that pulse oximeters often overestimate oxygen levels in Black patients, potentially delaying treatment and increasing health risks, a news release states.
Existing devices already on the market will not need to meet these new standards unless manufacturers request updates or modifications.
The FDA will accept public comments on the draft proposal for 60 days before finalizing the guidelines.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

© 2025 HealthDay. All rights reserved.
Posted January 2025
Read this next
Nearly Two-Thirds of U.S. Adults Have Experienced In-Person Gun Violence
WEDNESDAY, May 7, 2025 -- There are significant racial/ethnic and socioeconomic disparities in gun violence exposure (GVE) within the United States, according to a study published...
Quality Improvement Program Aids Antibiotic Duration for Common Infections in Children
WEDNESDAY, May 7, 2025 -- A quality improvement program can improve recommended antibiotic duration in children for both acute otitis media (AOM) and community-acquired pneumonia...
Sustainable Development Strategies Can Reduce Global Antimicrobial Resistance
WEDNESDAY, May 7, 2025 -- Sustainable development strategies are important for helping low- and middle-income countries to address the dual challenges of climate change and...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.