Pulse oximeters for medical purposes - non-clinical and clinical performance testing, labeling, and premarket submission recommendations.
Pulse oximeters for medical purposes - non-clinical and clinical performance testing, labeling, and premarket submission recommendations. Food and Drug Administration. January 06, 2025;
Pulse oximeters are known to be less accurate on persons of color, creating the potential for unsafe care. This draft guidance shares regulatory recommendations to improve the performance and appropriate labeling of pulse oximeters to improve its safe use throughout health care. The comment submission process will close on March 10, 2025.