Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations Draft Guidance for Industry and Food and Drug Administration Staff January 2025

This draft guidance document provides the FDA’s recommendations regarding non-clinical and clinical performance testing to support premarket submissions for pulse oximeters for medical purposes, including devices with a pulse oximeter function that estimates the amount of oxygen in arterial blood and pulse rate.  The recommendations are being made based in part on concerns that the accuracy of pulse oximeters can be affected by, among other factors, a person’s skin pigmentation. The recommendations are being provided to inform the performance evaluation for these devices, to support premarket submissions, regardless of submission type, and to promote consistency and facilitate efficient review of these submissions. Among other topics, the draft guidance also provides recommendations for labeling, which are intended to promote the safe and effective use of pulse oximeters and help users understand the benefits and risks associated with the use of the device.