Pulse check: Newly proposed FDA guidance

African American person using pulse oximeter

The U.S. Food and Drug Administration (FDA) has published new draft guidance on testing and using pulse oximeters. The purpose of the document, “Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance, Testing, Labeling and Premarket Submission Recommendations,” is to improve the accuracy and performance of pulse oximeters, particularly in people with skin of color.

Current scientific evidence suggests the accuracy of pulse oximeters varies based on the skin pigmentation of individuals. In 2021, the FDA notified the public that pulse oximeters carry limitations and are less precise in certain scenarios. For example, it said the device often overestimates oxygen levels in patients with darker skin, which can delay treatment and increase health risks.

The agency’s 2025 guidance helps address this concern by proposing how to gather clinical data, improve clinical study designs and better validate performance metrics of pulse oximeters used across the range of skin pigmentation. 

Additional components of the draft guidance include:

  • Including a minimum of 150 participants of diverse skin tones in all clinical trials, with at least 25% of dark color (up from 15%)
  • Using multiple methods to standardize the assessment of participants’ skin tone, including subjective (Monk Skin Tone Scale) and objective techniques (individual typology angle calculation) to scientifically measure levels of melanin
  • Adding or updating device labeling statements once performance accuracy has been successfully demonstrated across groups of individuals with diverse skin pigmentation

According to the FDA, the updated recommendations only apply to pulse oximeters that are intended for medic al purposes, such as for use in hospital or office settings to aid in clinical decision-making and medical intervention. Those sold to consumers as general wellness or sporting products, which are not FDA-regulated, do not fall under the guidance.

Individuals can submit comments and concerns on the guidance up to March 10, at which point the FDA will review all feedback prior to finalization. (Submit under docket number FDA-2023-N-4976.)

The FDA’s proposal is based on data from two FDA-funded prospective clinical studies, controlled laboratory desaturation testing, real-world performance in hospital and outpatient settings and scientific evidence from clinicians, scientists, manufacturers and other interested parties.

The FDA also incorporated input from two advisory committee meetings as well as a 2023 discussion paper which analyzed the accuracy of pulse oximeters and means to evaluate and improve their performance while taking into account an individual’s skin color.

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