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Sex-Specific Considerations in Medical Device Clinical Studies: Patient Enrollment, Data Analysis and Reporting

This guidance outlines FDA's expectations regarding sex-specific patient enrollment, data analysis, and reporting in medical device clinical studies. It applies to devices requiring clinical information for marketing submissions (510(k), PMA, de novo, HDE) and post-approval/surveillance studies. The guidance aims to improve data quality regarding device performance in both sexes by encouraging appropriate enrollment and analysis by sex.

  1. Develop enrollment strategy to achieve appropriate sex representation based on disease prevalence
  2. Include pre-specified plan for sex-specific analyses in study protocol
  3. Monitor enrollment demographics and investigate reasons for under-representation
  4. Conduct analyses of primary endpoints stratified by sex
  5. Report sex-specific enrollment, baseline characteristics and outcomes in submissions
  6. Include sex-specific information in device labeling
  7. Consider post-market studies if sex-specific questions remain unresolved
  8. Consult with FDA if clinically meaningful sex differences are observed
  9. Implement retention strategies considering sex-specific barriers to participation
  10. For diagnostic devices, validate performance in both sexes

Key Considerations

Clinical testing

  • Enroll proportions of each sex appropriate to disease prevalence
  • Consider sex differences in disease etiology and pathophysiology
  • Evaluate sex-specific differences in primary safety and effectiveness endpoints
  • Consider powering studies to evaluate treatment effect for both sex groups if clinically meaningful differences are anticipated

Labelling

  • Report enrollment demographics by sex
  • Include sex-specific outcomes analyses in labeling regardless if pre-specified or post hoc
  • Describe covariates that might explain outcome differences between sexes
  • Report clinically meaningful sex differences in safety or effectiveness separately for women and men

Safety

  • Analyze primary safety endpoints by sex
  • Report sex-specific adverse events
  • Evaluate potential sex differences in safety outcomes

Other considerations

  • ISO 14155: Clinical investigation of medical devices for human subjects - Good clinical practice

Original guidance

  • Sex-Specific Considerations in Medical Device Clinical Studies: Patient Enrollment, Data Analysis and Reporting
  • HTML / PDF
  • Issue date: 2014-08-22
  • Last changed date: 2020-03-02
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Good Clinical Practice (GCP)
  • ReguVirta summary file ID: 15f96662c136289fc7e549a104588aca
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