FDA Issues Draft Guidance on Pulse Oximeters: Recommendations for Performance Testing and Labelling

The U.S. Food and Drug Administration (FDA) has issued a draft guidance document aimed at providing critical recommendations for the non-clinical and clinical performance testing of pulse oximeters intended for medical purposes. Pulse oximeters are essential tools used to measure oxygen saturation levels in the blood and pulse rate, offering healthcare providers and lay users a non-invasive method for assessing arterial oxygen levels.

This draft guidance emphasizes the need for manufacturers to carefully evaluate and document the accuracy of pulse oximeters, particularly in light of recent studies indicating that factors such as skin pigmentation may influence device performance, especially at lower oxygen saturation levels. The guidance outlines the necessary performance evaluations to ensure that pulse oximeters provide accurate and reliable results in a variety of user conditions.

In addition to performance testing, the FDA offers recommendations on labeling practices aimed at enhancing the safe and effective use of pulse oximeters. The guidance highlights the importance of transparent labeling to inform users about potential risks, such as inaccuracy due to factors like skin pigmentation or poor circulation, ensuring that both healthcare providers and patients are aware of these limitations.

Manufacturers are encouraged to integrate these recommendations into their premarket submissions to ensure compliance with FDA regulations. The guidance also underscores the importance of utilizing FDA-recognized consensus standards to support regulatory submissions and promote consistency in reviews.

For those interested in learning more about the FDA’s recommendations and how they may affect pulse oximeter performance and regulatory submission processes, the full draft guidance document is below.