FDA issues draft guidance on pulse oximeters
By HME News Staff
Updated 9:32 AM CST, Thu January 9, 2025
WASHINGTON – The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a range of skin pigmentations. The FDA is requesting comments on “Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling and Premarket Submission Recommendations” for 60 days, until March 10. The draft guidance includes information on “What do I need to know about oxygen concentrators,” “How are my oxygen levels monitored at home,” and “What do I need to know about pulse oximeters.” It also includes instructions for how to report problems with a device. To submit comments on the draft, go here.
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