Evaluation of Sex and Gender Differences in Medical Device Clinical Studies (DRAFT)
This guidance provides recommendations for considering and evaluating sex-specific and gender-specific data in medical device clinical studies, both premarket and postmarket. It applies to submissions containing clinical information including 510(k), PMA, De Novo, HDE, BLA, and IDE applications. The guidance aims to ensure sex and gender are appropriately considered in study design, conduct, analysis, and interpretation of results.
This is a draft guidance. Not for implementation.
Recommended Actions
- Develop scientific rationale considering potential sex/gender differences early in study design
- Create enrollment strategy to achieve representative proportions of participants
- Pre-specify sex/gender-specific statistical analyses in study protocol
- Collect and analyze data disaggregated by sex/gender
- Report enrollment demographics and outcomes by sex/gender in submissions
- Include appropriate sex/gender-specific information in device labeling
- Consider additional studies if meaningful sex/gender differences are identified
- Consult with FDA if sex/gender-specific questions arise during development
- Monitor enrollment and retention by sex/gender throughout study conduct
- Document methods used to determine sex and gender of study participants
Key Considerations
Clinical testing
- Studies should enroll representative proportions of participants consistent with sex/gender-specific disease prevalence
- Consider sex/gender-specific differences in diagnosis, treatment patterns, and outcomes
- Pre-specify plans for sex/gender-specific analyses
- Report enrollment demographics and outcomes by sex/gender
- Assess heterogeneity of treatment effects across sex/gender groups
Labelling
- Include sex/gender-specific information in device labeling
- Report any sex/gender-specific limitations of clinical studies
- Describe benefits and risks separately by sex/gender if meaningful differences exist
- Include sex/gender enrollment demographics and baseline characteristics
Safety
- Analyze primary safety endpoints by sex/gender
- Report safety outcomes separately if meaningful differences exist
- Consider additional safety studies if sex/gender differences are observed
Other considerations
- Consider strategies to improve enrollment and retention of underrepresented groups
- Assess potential confounding factors correlated with sex/gender
- For diagnostic devices, include data from all sex/gender groups in cutoff selection and validation
- Control Type 1 error rates when conducting multiple sex/gender analyses
- Consider postmarket studies if meaningful sex/gender differences are identified
Relevant Guidances
- Collection and Reporting of Race and Ethnicity Data in Clinical Trials
- Sex-Specific Considerations in Medical Device Clinical Studies: Patient Enrollment, Data Analysis and Reporting
- Format for Clinical Data Presentations in Orthopedic Implant Device Submissions
- Design Considerations for Medical Device Pivotal Clinical Studies
Original guidance
- Evaluation of Sex and Gender Differences in Medical Device Clinical Studies
- HTML / PDF
- Issue date: 2025-01-07
- Last changed date: 2025-01-06
- Status: DRAFT
- Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Postmarket, Premarket, Biologics
- ReguVirta summary file ID: 295e7fba953a6fdbd1bfb8368ff43ad7
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