FDA to Address Racial Bias in Pulse Oximeters with New Panel Meeting and Discussion Paper

The U.S. Food and Drug Administration (FDA) has announced plans to host a panel meeting early next year to address racial bias in pulse oximeters. This decision comes a year after a panel of experts discussed the issue amid evidence that many FDA-cleared pulse oximeters provide inaccurate results for individuals with darker skin. Half of the U.S. state attorneys general recently signed a letter urging the FDA to take urgent action to eliminate this inequity. In response, the FDA has scheduled a virtual meeting for February 2, open to the public, to discuss racial biases in pulse oximeters. The meeting will involve the anesthesiology and respiratory therapy devices panels of the FDA's medical devices advisory committee.

The FDA's discussion paper outlines a new approach to improving studies of pulse oximeters, ensuring they work properly for people of all races before submission for premarket review. The proposed approach mandates a clinical study design that includes "the entire range of skin pigmentation found in U.S. racial and ethnic groups." The FDA's previous guidance recommended including "at least 2 darkly pigmented participants or 15% of the participant pool, whichever is larger." The new approach aims to ensure trial participants represent the entire spectrum of skin tones, with at least six individuals, or 25% of the participant pool, having the darkest skin tones.

Become a Subscriber

Please purchase a subscription to continue reading this article.

Subscribe Now

The FDA's panel will also discuss potential new requirements for the type and amount of data needed in premarket review submissions to demonstrate that pulse oximeters are "equitable and accurate for all patients." This includes labeling requirements and guidelines for both prescription and over-the-counter devices. The FDA's actions align with requests from state attorneys general for new regulations requiring "demographically representative clinical trials" and clear labels warning about possible inaccuracies for patients with darker skin.

While the FDA highlighted its most recent actions, which included working with real-world studies and taking part in data analyses to evaluate accuracy levels based on skin pigmentation, the agency did not give the attorneys general's request for an update to the 2022 safety communications or a letter to healthcare providers outlining the most recent findings and treatment recommendations.

Jeff Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, stated, "The FDA continues to engage stakeholders, gather input from ongoing clinical research to help inform our decisions, and evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance. The FDA will keep the public informed as significant new information or recommendations become available."

This move by the FDA reflects ongoing efforts to address racial bias in medical devices and improve healthcare equity. The virtual panel meeting and discussion paper aim to address the concerns raised by state attorneys general regarding the accuracy of pulse oximeters for individuals with darker skin tones.