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Pulse Oximeters: New Initiatives on Accuracy

Through two new initiatives, the U.S. Food and Drug Administration (FDA) is working to ensure pulse oximetry is equitable and accurate for all patients. On February 2, 2024, the FDA will host a virtual public advisory committee meeting. Today, the FDA published a new discussion paper to obtain public comment. The FDA encourages your participation in both initiatives.

Get Involved

• Read the discussion paper, Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity. The public is invited to comment on the paper until January 16, 2024.
• Attend the virtual public meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee.

Questions? 

If you have questions about this announcement, contact the Division of Industry and Consumer Education.