FDA Issues Draft Guidance on Pulse Oximeters for Medical Purposes
January 07, 2025
January 07, 2025
WASHINGTON, Jan. 7 (TNSFR) -- The Food and Drug Administration (FDA) has released a draft guidance document addressing pulse oximeters for medical purposes. This document offers recommendations for non-clinical and clinical performance testing, labeling, and premarket submissions for devices that estimate arterial blood oxygen levels and pulse rates.
The guidance also highlights concerns regarding the accuracy of these devices, particularly how skin pigmentation can impact their pe . . .
The guidance also highlights concerns regarding the accuracy of these devices, particularly how skin pigmentation can impact their pe . . .