Introduction: A New Standard on the Horizon   On January 6, 2025 , the FDA released a draft guidance  titled Pulse Oximeters for Medical Purposes: Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations . This draft guidance updates and expands upon earlier 510(k) and performance expectations for pulse oximeters, placing renewed emphasis on accuracy across skin pigmentation  and non-disparate performance .   Crucially, the draft does