Evaluation of Sex-Specific Data in Medical Device Clinical Studies
This guidance outlines FDA's expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information in medical device clinical studies. It applies to devices requiring clinical information for marketing submissions (510(k), PMA, de novo, HDE) and post-approval studies. The guidance does not apply to devices intended for single-sex populations or certain IVD studies using de-identified specimens.
Recommended Actions
- Develop strategy to enroll representative proportions of women and men
- Include pre-specified plans for sex-specific analyses in study protocols
- Report descriptive statistics for outcomes by sex
- Analyze primary safety and effectiveness endpoints by sex
- Investigate clinically meaningful sex differences
- Include sex-specific information in labeling and marketing applications
- Consider barriers to enrollment and implement strategies to enhance participation
- Evaluate need for sex-specific claims or additional data collection
- Monitor enrollment demographics throughout the study
- Consult with FDA if significant sex differences are observed
Key Considerations
Clinical testing
- Enroll proportions of women and men consistent with disease prevalence
- Consider sex differences in disease etiology and pathophysiology
- Investigate potential sex differences in safety and effectiveness outcomes
- Power studies appropriately if sex-specific differences are anticipated
- Consider sex-specific analyses in study design and statistical analysis plan
Human Factors
- Consider barriers to enrollment of women in clinical studies
- Address family responsibilities limiting study participation
- Provide flexibility in follow-up scheduling
- Consider providing childcare during appointments
Labelling
- Report enrollment demographics by sex
- Include sex-specific outcomes analyses in labeling
- Report clinically meaningful sex differences in safety or effectiveness
- Describe sex-specific baseline characteristics and comorbidities
- Include sex-specific information in summaries of safety and effectiveness
Safety
- Analyze primary safety endpoints by sex
- Report sex-specific adverse events
- Investigate potential sex differences in safety outcomes
- Consider sex-specific safety signals for additional evaluation
Other considerations
- Consider anatomical differences between sexes
- Evaluate potential confounding factors correlated with sex
- Assess treatment by sex interactions in comparative studies
- Consider separate reference intervals/cutoffs for diagnostic devices if needed
- Control Type 1 error rates for sex-specific claims
Relevant Guidances
- Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- Design Considerations for Medical Device Pivotal Clinical Studies
- Benefit-Risk Determinations for Medical Device Premarket Review
- Patient Engagement in Medical Device Clinical Studies: Roles, Benefits and Best Practices
Original guidance
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