FDA Proposes New Standards for Pulse Oximeters to Address Skin Tone Bias

The draft guidance calls for more diverse clinical testing to improve accuracy for patients with darker skin tones.

The FDA has released draft recommendations requiring pulse oximeter manufacturers to conduct more inclusive studies to ensure device accuracy across different skin tones.
The proposal highlights concerns that darker skin pigmentation may affect the accuracy of oxygen level readings, potentially delaying treatment for patients of color.
Key recommendations include enrolling at least 150 participants of varying skin tones, ensuring at least 25% of participants have darker skin, and using two methods to assess skin pigmentation in clinical trials.
The guidance applies only to professional pulse oximeters used in medical settings and excludes over-the-counter devices categorized as general wellness products.
The draft is open for public comment over the next 60 days before the FDA finalizes the guidelines.