On January 7, 2025, the FDA issued a draft guidance document on “Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies”. This draft guidance emphasizes the importance of inclusive and representative research to ensure devices are safe and effective for diverse populations. This guidance builds on the previous “Evaluation of Sex-Specific Data in Medical Device Clinical Studies” policy by expanding its scope to include both sex- and gender-specific considerations. It provides updated recommendations for sponsors to integrate these factors throughout the clinical study process, including study design, participant enrollment, data collection, analysis, and reporting.
Key objectives include encouraging study designs that reflect the demographics of the target population, ensuring proportional enrollment by sex and gender, and offering frameworks for analyzing and interpreting sex- and gender-specific outcomes. The guidance also highlights the importance of transparently reporting such data to the FDA, enhancing the understanding of device performance across all user groups.
Historically, women, individuals with intersex traits, and those with diverse gender identities have often been underrepresented or excluded from clinical studies. This exclusion has resulted in significant knowledge gaps regarding the safety and efficacy of medical devices for these groups. Recognizing this, the guidance aims to address these historical disparities by fostering science-driven approaches that consider sex and gender throughout a device’s lifecycle. This document highlights FDA’s commitment to advancing equitable healthcare by promoting inclusive research practices. It ensures that clinical studies better reflect the demographic, clinical, and disease characteristics of the intended population, ultimately improving medical device development and performance.
Read the full guidance here.
