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for Medical Purposes-Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Published Date: 1/7/2025
Notice
Summary
The FDA is sharing draft rules to make sure pulse oximeters—those handy devices that check your blood oxygen and pulse—work well for everyone, no matter skin color. These new guidelines suggest how to test, label, and submit these devices for approval, aiming for safer and more accurate readings. Companies making these devices should check out the draft and send feedback by March 10, 2025, to help shape the final rules.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Testing to Address Skin Pigmentation Gaps
The FDA's draft guidance responds to evidence that some pulse oximeters show accuracy differences between lightly and darkly pigmented people. FDA panels on November 1, 2022 and February 2, 2024 found disparate performance in patients with dark skin and recommended standardizing skin pigmentation assessment as part of device performance testing.
Premarket Testing and Submission Expectations
The draft guidance recommends non-clinical and clinical performance testing (including consideration of skin pigmentation) to support premarket submissions for pulse oximeters, and states these recommendations apply regardless of submission type to promote consistency and efficient review.
Clearer Labeling on Device Limits
The draft guidance proposes labeling recommendations for pulse oximeters intended to promote safe and effective use and to help users understand benefits and risks of the device. These labeling changes are intended to inform lay users and healthcare providers about performance considerations, including factors that can affect accuracy.
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