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

What You Need to Know? 👇

What are FDA’s expectations for enrolling diverse populations in medical device clinical studies?

FDA expects sponsors to develop strategies to enroll diverse populations including representative proportions of age, racial, and ethnic subgroups consistent with the intended use population. This helps achieve unbiased treatment effect estimates in the general population.

How should age groups be categorized in medical device clinical studies?

Age should be grouped appropriately for the disease condition with discrete groupings. For example, older patients should be stratified (65-74 years, ≥75 years) rather than simply older/younger than 65. Pediatric patients are defined as those under 22 years of age.

What statistical analyses are required for demographic subgroup data in device studies?

Sponsors should conduct descriptive statistics and assess heterogeneity across demographic subgroups for primary safety and effectiveness endpoints. Pre-specified statistical analysis plans should include subgroup analyses with appropriate multiplicity adjustments when differences are anticipated.

When should demographic subgroup differences be reported in device labeling?

Subgroup differences should be reported when they are statistically significant and clinically meaningful, or when clinically meaningful but not statistically significant. If no differences are found, this should also be stated along with which analyses were conducted.

What barriers exist to enrolling diverse populations in medical device trials?

Common barriers include restrictive inclusion/exclusion criteria, lack of diverse investigators, patient concerns about randomization, language/cultural differences, trial logistics like transportation, and investigator perceptions about recruiting certain demographic groups being more difficult or expensive.

How should race and ethnicity data be collected in medical device studies?

FDA recommends using OMB standardized categories with ethnic and racial demographic data captured as two distinct categories. Patients may self-identify in both categories (e.g., Hispanic-White). More granular data may be important depending on disease prevalence in specific populations.

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What You Need to Do 👇

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

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Relevant Guidances 🔗

• Collection and Reporting of Race and Ethnicity Data in Clinical Trials
• Design Considerations for Medical Device Pivotal Clinical Studies

Related references and norms 📂

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

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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 ID: 74191746b2d7aaea1e46e6ac5377f732