- The Food and Drug Administration is seeking feedback on the use of pulse oximeters in people with darker skin pigmentation ahead of an advisory committee meeting next year.
- The agency, under pressure to mitigate the risk of bias, published a discussion paper on improving the performance evaluation of pulse oximeters, taking skin pigmentation, race and ethnicity into account.
- Feedback on the paper will inform the virtual public meeting of an advisory committee that the FDA has scheduled for February. The committee will discuss how to improve premarket studies and the type and amount of data that developers of pulse oximeters should submit for review.
The FDA held an advisory committee meeting to discuss pulse oximeters one year ago. Earlier this month, 25 state attorneys general wrote to the FDA to question the lack of changes since the meeting, noting that “pulse oximeters continue to be sold without clear warning labels or other guidance to protect individuals from harm.”
On Thursday, the FDA set out the next steps in its work on pulse oximeter devices in a statement that listed the actions it has taken since the earlier advisory committee meeting. The statement disclosed the date of the next advisory committee meeting, Feb. 2, and the publication of the discussion paper.
In the 12-page paper, the FDA describes the background on pulse oximeters and race, explaining how the COVID-19 pandemic brought the question of bias, which has been explored for decades, to the fore and led to a flurry of new papers. The FDA’s current guidance recommends that the devices undergo a laboratory study, and that participants have a range of skin pigmentations, including at least two darkly pigmented subjects or 15% of the participant pool, whichever is larger.
Now, the agency is “considering the utility of a clinical study design that includes a larger number of participants using an assessment that has been validated to capture race and ethnicity diversity in pigmentations within the United States, and is intended to result in a more inclusive and representative study of the intended patient population.”
The discussion paper goes on to outline possible components of clinical study designs, walking through a set of potential scales, ways of assessing skin pigmentation and approaches to considering race and ethnicity in performance analyses.
The FDA posed seven questions for stakeholders. Comments received by Jan. 19, 2024, will be provided to the committee, and the comment period will stay open until early March.