USFDA Guidance: Evaluation of Sex-Specific Data in Medical Device Clinical Studies (March 2025)
- Sharan Murugan
- Apr 5
- 2 min read
In March 2025, the U.S. Food and Drug Administration (FDA) released a final guidance titled “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.” This important document reflects FDA's continued commitment to promoting the inclusion and analysis of both male and female participants in clinical studies that support medical device approvals. The goal is to ensure that devices are safe and effective for everyone, regardless of sex.
This guidance is aimed at medical device manufacturers, clinical investigators, and sponsors. It provides recommendations on how to address sex differences in clinical trials from the early planning stages through regulatory submission.
Why This Guidance Matters
Medical devices may interact differently with male and female anatomy or physiology. For instance, devices like pacemakers, joint implants, or diagnostic tools could exhibit sex-specific performance or safety issues. Historically, women have been underrepresented in clinical trials, leading to data gaps.
This guidance ensures those gaps are addressed, promoting equity in evidence generation.
Key Recommendations from the Guidance
1. Enrollment Practices:
Sponsors should proactively enroll representative proportions of both women and men in their clinical studies unless scientifically justified otherwise.
2. Study Design & Analysis:
Study protocols should:
Include sex-specific enrollment targets.
Incorporate plans for sex-specific analyses of safety and effectiveness.
Include sample size justifications for both sexes where appropriate.
3. Data Collection & Reporting:
Report subject sex distribution in all phases of the study.
Present outcomes separately for men and women when statistically valid.
If analyses by sex are not conducted, justify.
4. Labeling Considerations:
If sex-based differences are identified, these should be reflected in:
Device labeling
Instructions for use
Warnings or precautions, if needed
Case Examples Highlighting Sex Differences
Ventricular Assist Devices (VADs): Women showed higher stroke rates (18% vs. 6% in men), potentially linked to smaller body surface area
Cardiac Resynchronization Therapy Defibrillators (CRT-D): Women experienced greater therapeutic benefit (77% vs. 42% reduction in heart failure events), possibly due to higher prevalence of left bundle branch block
Metal-on-Metal Hip Implants: Higher revision rates in women prompted postmarket studies to evaluate sex-specific failure risks
Implementation Tools
Decision Framework: A structured approach for integrating sex-specific analyses into study design
Statistical Templates: Pre-specified hypotheses and power calculations for sex subgroup analyses
This guidance is key to improving clinical study diversity and inclusive innovation. Sponsors are encouraged to integrate these recommendations into clinical development plans early and maintain transparency through consistent reporting.
By incorporating sex-specific analyses, the industry can better ensure that medical devices work safely and effectively for everyone.
For full details, refer to the official guidance:
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