Clinical studies must now include 25 percent of patients with darker skin tones
By Physician’s Briefing Staff HealthDay Reporter
TUESDAY, Jan. 7, 2025 (HealthDay News) — 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.
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