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

The U.S. Food and Drug Administration (FDA) has released updated guidance emphasizing the critical role of sex- and gender-specific data in the clinical evaluation of medical devices. Aimed at sponsors of premarket submissions, the guidance outlines recommendations for designing, conducting, and analyzing studies to ensure these factors are appropriately considered throughout the product lifecycle.

This initiative is part of the FDA’s commitment to promoting equitable healthcare outcomes and improving device safety and effectiveness for all demographic groups. The guidance encourages manufacturers to account for sex- and gender-related differences in device performance and safety, particularly in products where such factors may significantly impact outcomes. Additionally, it highlights the importance of representing diverse populations in clinical studies, including variables like age, race, and ethnicity, to better reflect real-world patient demographics.

The FDA also advises sponsors to consult this guidance in conjunction with relevant device-specific and cross-cutting regulatory recommendations. By integrating these practices, manufacturers can enhance the inclusivity, reliability, and regulatory compliance of their studies.

For those interested in the complete guidance, the full document is below.