Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies

Recommended Actions

1. Develop enrollment strategy to achieve appropriate demographic representation
2. Include pre-specified plans for demographic subgroup analyses in study protocols
3. Implement measures to enhance diverse enrollment and retention:
   • Select diverse study sites
   • Provide flexible scheduling
   • Use culturally appropriate materials
   • Monitor enrollment demographics
4. Analyze and report:
   • Enrollment demographics
   • Baseline characteristics by subgroup
   • Safety and effectiveness outcomes by subgroup
   • Any clinically meaningful differences
5. Address any observed demographic differences:
   • Investigate potential causes
   • Consider impact on benefit-risk profile
   • Determine if additional data needed
   • Update labeling as appropriate
6. Consider postmarket data collection needs for demographic subgroups
7. Include comprehensive demographic information in submissions and public documents

Key Considerations

Clinical testing

• Develop strategy to enroll diverse populations reflecting intended use population
• Pre-specify plans for subgroup analyses in Statistical Analysis Plan
• Consider proper study design and sufficient enrollment when differences are anticipated
• Investigate heterogeneity across demographic subgroups
• Address confounding using multivariable analyses

Human Factors

• Consider flexibility in follow-up visit scheduling
• Consider providing child care or elder care services during appointments
• Consider alternative communication strategies for study recruitment and materials

Labelling

• Include demographic enrollment data and proportions
• Report outcome analyses by demographic subgroup
• Describe how differences affect benefit-risk profile
• Include discussion of clinically meaningful differences
• Provide clear statements about analyses conducted

Safety

• Examine data for clinically meaningful demographic differences in safety endpoints
• Report safety outcomes by demographic subgroup
• Investigate causes of any observed differences

Other considerations

• Consider site selection to facilitate diverse enrollment
• Monitor follow-up rates closely
• Obtain proxy contact information
• Consider cultural competency training for investigators
• Address barriers to enrollment
• Investigate reasons for under-enrollment
• Consider postmarket data collection needs

  Relevant Guidances

• Collection and Reporting of Race and Ethnicity Data in Clinical Trials
• Design Considerations for Medical Device Pivotal Clinical Studies
• Evaluation of Sex and Gender Differences in Medical Device Clinical Studies (Draft)

Related references and norms

• 21 CFR 814.3(s): Definition of pediatric patients
• 21 CFR 812.25(c): Requirements for investigational plan

---

Original guidance

• Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies
• HTML / PDF
• Issue date: 2017-09-12
• Last changed date: 2024-04-08
• Status: FINAL
• Official FDA topics: Physical Medicine, Laboratory Tests, IVDs (In Vitro Diagnostic Devices), Clinical Chemistry & Clinical Toxicology, HUD/HDE, Orthopedic, Clinical - Medical, Nose & Throat, Radiation-Emitting Products, Hematology & Pathology, Gastroenterology-Urology, 510(k), Premarket, Ear, Immunology & Microbiology, Biologics, Radiological Health, Investigational Device Exemption (IDE), Radiology, Ophthalmic, Medical Devices, Good Clinical Practice (GCP), Obstetrical & Gynecological, Cardiovascular, Labeling, General Hospital & Personal Use, Molecular and Clinical Genetics, Pediatric Product Development, General & Plastic Surgery, Premarket Approval (PMA), Dental, Neurological
• ReguVirta summary file ID: 74191746b2d7aaea1e46e6ac5377f732