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FDA issues draft guidance on pulse oximeters 

January 9, 2025HME News Staff

WASHINGTON – The U.S. Food and Drug Administration on Jan. 6 issued new draft guidance to help improve the accuracy and performance of pulse oximeters that are used for medical purposes across populations with a range of skin pigmentations.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 The draft guidance includes information...

draft guidance, Food & Drug Administration (FDA), Oxygen Concentrator, Pulse oximeters

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