FDA Issues Draft Guidance on Pulse Oximeters: Recommendations for Performance Testing and Labelling

The FDA’s draft guidance on pulse oximeters provides critical recommendations for non-clinical and clinical performance testing, addressing concerns about factors such as skin pigmentation and oxygen saturation levels. The guidance emphasizes the importance of accurate evaluations to ensure reliable results in diverse conditions. Manufacturers are advised to follow FDA-recognized consensus standards and integrate these recommendations into premarket submissions for regulatory compliance. Additionally, the guidance highlights transparent labeling practices, informing users of potential limitations, such as inaccuracy due to poor circulation or pigmentation. This comprehensive approach ensures that both healthcare providers and patients can trust pulse oximeter data for critical health decisions.