FDA Issues Guidance on Incorporating Sex- and Gender-Specific Data in Medical Device Clinical Studies

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.