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  1. Medical Devices News and Events

CDRH Takes Steps to Advance Further Discussions on Pulse Oximeters

FOR IMMEDIATE RELEASE
November 16, 2023

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health


Today, CDRH is announcing that we will hold a virtual public meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee on February 2, 2024 to discuss pulse oximeters. 

The meeting will include discussions about a new approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters submitted for premarket review, taking into consideration a patient’s skin pigmentation and patient-reported race and ethnicity. The Committee will also discuss the type and amount of data that should be provided by manufacturers to the FDA to evaluate the performance of pulse oximeters submitted for premarket review, including prescription and over-the-counter indications, and labeling considerations, to ensure pulse oximetry is equitable and accurate for all patients. 

Additionally, today the agency published a discussion paper, Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity. Our hope is that this discussion paper and request for feedback will help to engage stakeholders and obtain public comment about concerns with pulse oximetry before the upcoming virtual public meeting. These actions were informed by the discussion from the November 2022 meeting of this advisory committee where stakeholders shared information and perspectives about ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentation.

Before, and following the advisory committee meeting in November 2022, the FDA has:

  • Worked closely with two FDA-funded real-world evidence studies at UCSF-Stanford Center for Excellence in Regulatory Science and Innovation, to prospectively evaluate the performance of pulse oximeters in adults and children using simultaneous oximetry measurements and objective skin pigmentation measurement. This work aims to address some limitations of previously published real-world studies.
  • Conducted additional analysis of premarket data, as well as worked with outside stakeholders, including manufacturers and testing laboratories, to analyze additional postmarket data to better understand how different factors including skin pigmentation may affect pulse oximeter accuracy.
  • Issued several public communications in June, September, and November 2022 to continue efforts to keep the public informed of the FDA’s actions related to pulse oximeters.
  • Provided a 24-hour Summary of the meeting in November 2022 to keep the public informed about the discussion topics and the panel’s recommendations. 
  • Taken proactive steps to improve premarket evaluation strategies and equitable device performance to help improve the accuracy of pulse oximeters across all U.S. patient populations and demographics. 
  • Focused more closely on literature that evaluates whether products may be less accurate in individuals with darker skin pigmentation.

Although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy under certain circumstances that should be considered. 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. 

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