Medical Device Clinical Trial Diversity: FDA Diversity Action Plans, FDORA Requirements, and Strategies for Representative Device Studies

What This Article Covers

Clinical trials for medical devices have historically underrepresented the populations most likely to use the devices after approval. This problem is not abstract. Cardiac devices approved on predominantly male trial data may perform differently in women. Insulin delivery systems tested primarily in white populations may not account for physiological and socioeconomic factors that affect outcomes in Black and Hispanic patients with diabetes. Implantable neurostimulators studied in adults under 65 provide limited evidence for the growing elderly population that will actually receive them.

The Food and Drug Omnibus Reform Act of 2022 (FDORA) created a new legal mandate: sponsors of Phase 3 drug trials and pivotal device studies must submit Diversity Action Plans (DAPs) to FDA. Sections 3601 and 3602 of FDORA added new sections 505(z) and 520(g)(9) to the FD&C Act, requiring sponsors to specify enrollment goals disaggregated by race, ethnicity, sex, and age group, along with the rationale for those goals and the strategies to achieve them.

This article covers the DAP requirements as they apply to medical device clinical investigations, the current status of FDA's draft guidance, device-specific considerations for enrollment goal setting, practical strategies for representative enrollment, and how device sponsors can prepare for compliance before the mandate takes effect.

What This Article Does NOT Cover

This is not a general guide to medical device clinical trial design. For that, see the Medical Device Clinical Trials IDE Guide, the ISO 14155 Clinical Investigation Guide, and the Decentralized Clinical Trials Guide. For FDA reporting requirements during trials, see the Medical Device Adverse Event Reporting Guide.

The Regulatory Foundation

FDORA Sections 3601 and 3602

Section 3601 of FDORA amended the FD&C Act by adding:

• Section 505(z) — requiring DAPs for drug clinical studies
• Section 520(g)(9) — requiring DAPs for device clinical investigations

Both sections require sponsors to submit a DAP that specifies goals for clinical study enrollment, disaggregated by the race, ethnicity, sex, and age group demographic characteristics of the clinically relevant population.

Section 3602 directed FDA to issue or update guidance on the format and content of DAPs within 12 months of FDORA's enactment. The mandate becomes effective 180 days after FDA publishes the final guidance.

FDA Draft Guidance (June 2024)

FDA published "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies" in June 2024, replacing the earlier April 2022 draft guidance that focused solely on racial and ethnic populations. The 2024 draft guidance:

• Expands the required demographic categories to include race, ethnicity, sex, and age group
• Encourages sponsors to also consider geographic location, gender identity, sexual orientation, physical and mental disabilities, pregnancy status, lactation status, and comorbidity
• Describes the form, content, and manner of DAP submissions
• Specifies the applicable medical products and clinical studies
• Outlines waiver criteria and the process for requesting waivers

As of May 2026, this guidance remains in draft form. The DAP submission requirement will apply to clinical studies for which enrollment commences after 180 days from publication of the final guidance.

Related FDA Guidance Documents

Several existing FDA guidance documents inform diversity expectations for device studies:

Which Device Studies Require a DAP

Applicability Criteria for Devices

Under FDORA section 520(g)(9), a DAP is required for device clinical investigations that meet both of the following conditions:

1. The study is a pivotal investigation. This includes studies intended to support a Premarket Approval (PMA) application, a De Novo classification request, a Humanitarian Device Exemption (HDE) application, or a 510(k) submission that includes new clinical data as the primary basis for substantial equivalence.

2. The study enrolls human participants. Bench testing, animal studies, and retrospective data analyses are excluded.

Studies Exempt from DAP Requirements

The following device studies are generally exempt:

• 510(k) submissions based on substantial equivalence without new clinical data
• Bench performance testing and analytical validation studies
• Retrospective chart reviews and database analyses
• Studies with a single participant (n=1, such as certain custom device cases)
• Studies for which FDA grants a waiver

Waiver Criteria

FDA may grant a waiver from the DAP requirement when:

• The study is for a rare disease or condition where enrollment of a representative population is impractical
• The sponsor demonstrates that enrollment goals cannot be met despite good-faith efforts
• A public health emergency necessitates rapid study initiation
• FDA determines that a DAP is unnecessary for the specific study

Waiver requests must be submitted with supporting documentation explaining why the sponsor cannot meet the DAP requirements.

DAP Content Requirements for Device Studies

The DAP must contain three core elements, tracking the statutory language of FDORA:

Element 1: Enrollment Goals

Enrollment goals must be disaggregated by four required demographic categories:

• Race (e.g., White, Black or African American, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander)
• Ethnicity (e.g., Hispanic or Latino, Not Hispanic or Latino)
• Sex (Male, Female)
• Age group (e.g., 18–39, 40–64, 65+)

Goals should be tied to the estimated prevalence or incidence of the disease or condition in the U.S. population that is expected to use the device. For devices targeting the entire population (such as certain general hospital supplies), U.S. Census data may serve as the reference.

Device-specific nuance: For medical devices, the intended use population is often defined by the clinical condition rather than a drug's pharmacokinetic profile. A cardiac rhythm management device, for instance, serves a population with age and comorbidity distributions that differ markedly from the general population. The enrollment goals must reflect the disease-specific demographics, not census proportions.

Element 2: Rationale for Enrollment Goals

The rationale section must explain:

• The estimated prevalence or incidence of the disease or condition in the U.S. by demographic group
• How the sponsor determined that the proposed enrollment goals are appropriate
• Any deviation from prevalence-based proportions, with justification (e.g., the need to over-enroll a subgroup to detect clinically meaningful differences)
• For multi-regional studies, how the global enrollment strategy accounts for the need to enroll a representative sample of the U.S. intended-use population

The rationale should reference specific epidemiological data sources, such as CDC prevalence estimates, NIH disease-specific statistics, published clinical literature, or real-world evidence databases.

Element 3: Measures to Meet Enrollment Goals

This section must describe specific, actionable strategies for enrolling and retaining participants from underrepresented populations. FDA encourages sponsors to consult with patients and healthcare providers to identify enrollment and retention barriers during DAP development.

Acceptable strategies include:

• Community engagement: Sustained outreach to community health organizations, faith-based institutions, and advocacy groups serving underrepresented populations
• Cultural competency training: Required training for investigators and research staff on cultural awareness, health literacy, and communication with diverse patient populations
• Language accessibility: Translation of informed consent documents, patient-reported outcome instruments, and study materials into languages spoken by target enrollment populations
• Financial and logistical burden reduction: Reimbursement for transportation, childcare, and time off work; provision of mobile study visits; flexible scheduling
• Site selection: Deliberate inclusion of study sites in geographic areas with diverse patient populations, including community hospitals, safety-net hospitals, and federally qualified health centers
• Decentralized trial elements: Use of telemedicine, wearable monitoring, direct-to-patient shipping, and home health visits to expand geographic reach
• Over-enrollment strategies: When justified by scientific rationale, enrolling a higher proportion of a specific demographic group to enable subgroup analyses

Device-Specific Diversity Challenges

Challenge 1: Small Enrollment Populations

Many device clinical investigations enroll far fewer participants than drug trials. A pivotal orthopedic implant study may enroll 200–400 patients, compared to thousands in a drug Phase 3 trial. With small sample sizes, achieving enrollment goals for multiple demographic subgroups can be statistically and operationally difficult.

Practical approach: Focus on the demographic dimensions most relevant to device safety and effectiveness. For an implantable cardioverter-defibrillator, sex and age may be more clinically significant than race for certain endpoints. Document the rationale for prioritizing specific demographic dimensions and consider Bayesian adaptive designs that allow enrollment adjustments as data accumulates.

Challenge 2: Geographically Concentrated Expertise

Complex device procedures (TAVR, deep brain stimulation, robotic surgery) are typically performed at specialized centers that may not serve diverse patient populations. Academic medical centers in major metropolitan areas may have diverse patient bases, but high-volume specialty centers in less diverse regions create enrollment challenges.

Practical approach: Expand the site network to include institutions in diverse metropolitan areas, even if they are not traditional research centers. Provide additional training and support to sites that are new to clinical research but serve underrepresented populations. Consider allowing certain protocol assessments to be performed at satellite sites or through remote monitoring.

Challenge 3: Inclusion and Exclusion Criteria That Disproportionately Exclude

Device clinical investigations often have extensive exclusion criteria related to anatomy, comorbidities, or prior interventions that may disproportionately exclude specific demographic groups. For example, body size requirements for implantable devices may disproportionately exclude women and certain ethnic populations with smaller body habitus.

Practical approach: Review inclusion and exclusion criteria through a health equity lens. FDA's December 2025 guidance on enhancing clinical trial participation explicitly recommends avoiding unnecessary exclusions related to older age, weight extremes, HIV status, or disabilities. Justify any exclusion that could disproportionately affect a demographic group with a scientific or safety rationale.

Challenge 4: Postmarket Surveillance Integration

Device clinical trials are often smaller and shorter than drug trials, making postmarket data collection critical for understanding device performance across diverse populations. The DAP should consider how postmarket surveillance will supplement the clinical investigation.

Practical approach: Link the DAP to the postmarket surveillance plan. Specify how the sponsor will continue to collect demographic-specific performance data after approval through registries, real-world evidence, and postmarket clinical follow-up (PMCF) studies. This is particularly important for devices approved through the 510(k) pathway where clinical data may be limited.

Building a DAP for a Device IDE Submission

Timing

For device studies requiring an Investigational Device Exemption (IDE), the DAP should be submitted as part of the IDE application. FDA recommends engaging early with the reviewing division through the pre-submission (Q-Submission) process to discuss DAP development.

Step-by-Step Process

Step 1: Define the intended-use population. Review the device's intended use, indications for use, and target patient population. Identify the demographic characteristics of the U.S. population with the disease or condition the device addresses.

Step 2: Gather epidemiological data. Use CDC WONDER, NIH databases, published literature, and registry data to estimate disease prevalence or incidence by race, ethnicity, sex, and age group. For rare conditions, consult Orphanet, GARD, or disease-specific patient registries.

Step 3: Set enrollment goals. Calculate target enrollment proportions based on disease-specific demographics. Document any instances where enrollment goals deviate from disease prevalence proportions and provide scientific justification.

Step 4: Identify enrollment barriers. Conduct a formal barrier assessment that considers:

• Geographic access to investigational sites
• Insurance and reimbursement for study procedures
• Health literacy and language barriers
• Historical mistrust of clinical research in specific communities
• Caregiver and logistical support needs

Step 5: Develop targeted strategies. Design specific, measurable strategies for each identified barrier. Assign responsibility, timeline, and budget for each strategy.

Step 6: Define monitoring metrics. Specify how the sponsor will track demographic enrollment during the study and what actions will be taken if enrollment deviates from goals. Include interim analysis checkpoints.

Step 7: Plan for postmarket follow-up. Describe how the sponsor will continue to collect and analyze demographic-specific performance data after the study, including linkage to the postmarket surveillance plan.

EU Perspective: Diversity in Device Clinical Investigations

While the EU does not have a DAP mandate equivalent to FDORA, the EU Clinical Trials Regulation (CTR) and MDR Annex XIV require that clinical investigations be designed to represent the target population. ISO 14155:2011, which governs clinical investigations of medical devices in humans, states that the choice of subjects should reflect the intended use population.

The EU's approach to diversity is embedded in the broader ethical and scientific framework rather than mandated through a specific submission requirement. However, as the EU MDR evolves and the EU AI Act introduces additional requirements for algorithmic fairness in AI-enabled medical devices, demographic representation in clinical data will become increasingly scrutinized by notified bodies and competent authorities.

FDA's Annual Diversity Report

Section 3604 of FDORA requires FDA to annually submit to Congress and publish on its website a report summarizing the DAPs received and whether clinical studies met their demographic enrollment goals. The first report, covering FY 2023 and FY 2024, was published in late 2024 and provides baseline data.

Key findings from the report:

• FDA received voluntary diversity plans for some clinical studies conducted between October 2022 and September 2024, even though the DAP mandate had not yet taken effect
• The report highlights that certain sponsors have initiated the process of preparing and submitting diversity plans ahead of the mandate
• Data on whether enrollment goals were met will become more meaningful once the mandate takes effect and a larger dataset accumulates

Device sponsors should review this report to understand the scope of information FDA expects and the level of detail in DAP submissions.

Practical Strategies for Device Sponsors

Strategy 1: Start Before the Mandate

The DAP requirement will apply to studies beginning enrollment 180 days after the final guidance is published. Given the lead time for device study planning, sponsors should begin integrating diversity considerations now:

• Include demographic enrollment targets in study design protocols
• Conduct site feasibility assessments that evaluate the demographic composition of each site's patient population
• Budget for community engagement, translation services, and patient navigation programs

Strategy 2: Leverage Real-World Data for Goal Setting

For devices targeting conditions with limited epidemiological data by demographic group, real-world data sources can help estimate the intended-use population:

• EHR databases (e.g., Optum, Flatiron Health) can provide demographic breakdowns of patients with the target condition
• Claims databases can quantify procedure volumes by demographic group
• Device registries (e.g., TVT Registry, NCDR) provide real-world utilization data with demographic detail

Strategy 3: Use Decentralized Clinical Trial Elements

Decentralized clinical trial (DCT) methodologies can significantly expand geographic and demographic reach:

• Remote consent and enrollment processes reduce the barrier for patients who cannot travel to study sites
• Wearable monitoring and home-based assessments allow participation from geographically diverse locations
• Direct-to-patient device shipping (where appropriate) removes the requirement for initial site visits

For a comprehensive framework, see the Decentralized Clinical Trials Guide.

Strategy 4: Build Community Partnerships Early

Effective community engagement requires sustained investment, not a transactional outreach campaign:

• Partner with community health organizations, patient advocacy groups, and professional organizations serving underrepresented populations
• Include community representatives on study advisory boards
• Provide study results back to participating communities in accessible formats

Strategy 5: Integrate DAP with the PMS Plan

For medical devices, the DAP should not be a standalone document. Connect it to:

• The postmarket surveillance plan (how will demographic-specific safety and effectiveness data be collected after approval?)
• The PMCF plan (what follow-up studies will enroll diverse populations?)
• The clinical evaluation report (how will real-world demographic data be integrated into ongoing benefit-risk assessment?)

Key Takeaways

1. DAPs will be mandatory for pivotal device studies. FDORA sections 3601–3602 require DAPs with enrollment goals disaggregated by race, ethnicity, sex, and age group for IDE studies intended to support marketing authorization.

2. The mandate takes effect 180 days after FDA finalizes its guidance. As of May 2026, the June 2024 draft guidance has not been finalized. Device sponsors should prepare now rather than wait.

3. Enrollment goals must reflect disease-specific demographics, not census data. The reference population is the U.S. population expected to use the device, defined by the disease or condition it addresses.

4. Device studies face unique challenges. Small enrollment populations, geographically concentrated expertise, and extensive exclusion criteria create barriers to representative enrollment that require creative, proactive strategies.

5. Postmarket surveillance is part of the diversity story. Device trials are often too small and too short to capture all demographic-specific outcomes. The DAP should connect to the PMS plan and PMCF activities.

Sources

• Food and Drug Omnibus Reform Act of 2022 (FDORA), Sections 3601–3604.
• FDA, "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies," Draft Guidance, June 2024.
• FDA, "Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs," Final Guidance, December 2025.
• FDA, "Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies," Final Guidance, September 2017.
• FDA, "Diversity Action Plans Summary: FY 2023 and FY 2024."
• Hyman, Phelps & McNamara, "Under FDORA, FDA to Require Most Drug and Device Trials to Submit Diversity Action Plans," January 2023.
• Foley Hoag, "Action Plans on Diversity: Key Requirements for Certain Clinical Studies," July 2024.
• Troutman Pepper, "Updated FDA Draft Guidance Instructs Sponsors on Content, Format, Timing, and Procedures for Submitting Diversity Action Plans," July 2024.
• Milken Institute, "Statement on Newly Released FDA Guidance on Diversity Action Plans," 2024.