FDA Issues Guidance on Evaluating Gender-Specific Data in Medical Device Clinical Trials

The Food and Drug Administration (FDA) has issued an update to its guidance on the evaluation of gender-differentiated data in clinical studies of medical devices. This revised version, published in March 2025, aims to improve the representation of women and the analysis of gender-specific data, contributing to a more robust assessment of the safety and effectiveness of medical devices in different populations.

Why is this guidance relevant?

The FDA recognizes that biological and physiological differences between genders—such as body size, metabolism, hormones, morphology, or predisposition to certain conditions—can influence the clinical outcomes of medical devices. The document emphasizes that the underrepresentation of women in clinical studies has historically limited understanding of the risks and benefits of devices when used in female populations.

Key recommendations from the FDA

1. Study Planning:
   Sponsors should consider potential gender differences from the study design phase, ensuring proportional inclusion of women and men based on the prevalence of the condition being treated.

2. Study Design and Conduct:
   The selection of recruitment centers, inclusion/exclusion criteria, and retention strategies should be adapted to facilitate participation by both genders.

3. Statistical Analysis:
   Methodologies should be applied that allow for the identification of heterogeneity in results between men and women, including treatment-gender interaction tests and analysis adjusted for covariates (e.g., body mass index, comorbidities).

4. Presentation of Results:
   Results by gender should be included in clinical reports, regulatory submission documents, and device labeling. The absence of differences should also be reported and justified.

5. Post-Marketing Studies:
   When preliminary data indicate potential gender differences, the FDA may require specific post-approval studies to further the clinical evidence.

Implications for manufacturers

For medical device manufacturers, this guidance underscores the need to systematically incorporate gender into their clinical and regulatory development strategies. The approach recommended by the FDA contributes to:

• A more accurate assessment of the benefit-risk profile;

• Greater transparency in labeling and communication with healthcare professionals and end users;

• Reduced regulatory risk during the review of submissions by the FDA.

Read the full document below.