The FDA's updated guidance emphasizes the importance of including sex- and gender-specific data in medical device clinical studies, urging manufacturers to address differences in device performance and safety related to these factors. By considering variables like age, race, and ethnicity, the guidance promotes inclusivity and ensures studies reflect real-world patient demographics. Sponsors are encouraged to integrate these practices alongside device-specific recommendations to enhance reliability, regulatory compliance, and healthcare equity. This approach aligns with the FDA's commitment to improving outcomes for diverse populations through comprehensive and inclusive clinical evaluations.

The FDA’s draft guidance on pulse oximeters provides critical recommendations for non-clinical and clinical performance testing, addressing concerns about factors such as skin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.