How Latin America Helps Sponsors Meet FDA Diversity Requirements for Pivotal Medical Device Trials

Learn how Latin America's ethnic diversity helps medical device sponsors meet FDA diversity action plan requirements for pivotal trials. Explore country-by-country demographic profiles and strategic site selection with bioaccess®.

March 23, 2026

6

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

FDA Diversity

Clinical Trials

Latin America

Pivotal Trials

Medical Devices

Patient Diversity

Why FDA Diversity Requirements Matter for Your Pivotal Trial Strategy

The FDA Omnibus Reform Act of 2022 (FDORA) fundamentally changed how sponsors must approach pivotal clinical trials. Under these new requirements, sponsors must submit Diversity Action Plans (DAPs) for pivotal and confirmatory studies — documenting how they will enroll participants that reflect the demographics of the intended patient population.

A DAP must include:

• Demographic composition of the intended patient population by race, ethnicity, sex, and age.
• Enrollment goals that mirror the target population's diversity profile.
• Rationale for clinical site selection — explaining why chosen sites can access diverse populations.
• A plan to mitigate barriers to diverse enrollment, including logistical and cultural considerations.

**⚠️ Important Distinction: Pivotal vs. Early-Stage Trials**

These DAP requirements target pivotal and confirmatory studies, NOT early-stage or first-in-human (FIH) trials. However, this creates a strategic opportunity: sponsors can use Latin American FIH data as a foundation for their diversity strategy — developing sites, investigators, and patient recruitment pipelines that carry forward into the pivotal phase.

Latin America's Unique Diversity Advantage

Unlike the United States or Europe, Latin America offers access to indigenous, African-descent, European, mestizo, and Asian communities across one ICH-GCP compliant region. This unparalleled ethnic diversity is distributed across countries with established regulatory frameworks and experienced clinical investigators.

A single CRO partner like bioaccess® can help sponsors access all of these populations through a coordinated, multi-country clinical strategy — something no other region can offer at the same cost and regulatory efficiency.

**🌎 One Region, Every Demographic**

Latin America is the only region in the world where sponsors can access indigenous Mayan/Aztec populations, Afro-Caribbean communities, European-descent cohorts, and Asian-ancestry groups — all within a single regulatory and operational framework. This makes it the ideal strategic partner for sponsors building their FDA diversity strategy.

Regional Ethnic Profiles: Country-by-Country Guide

Each Latin American country offers a distinct demographic profile. Understanding these differences allows sponsors to strategically select sites that match their DAP requirements.

Primarily indigenous ancestry with Mayan and Aztec heritage. The population is predominantly mestizo (mixed indigenous-European), making El Salvador ideal for trials targeting indigenous or mestizo populations. With 6.5 million people and the highest population density in the Americas, patient recruitment is efficient and concentrated.

One of the most ethnically diverse countries in the Americas. African-descent communities concentrate along the Caribbean and Pacific coasts, indigenous populations (Wayuu, Emberá, Nasa) inhabit the Andes and Amazon regions, and European-descent populations are concentrated in Bogotá and Medellín. Colombia's 52 million population offers scale and diversity in a single country.

Strong African influence from historical demographics, with a large Afro-Caribbean population. The Dominican Republic is particularly well-suited for trials requiring African-descent participants and offers an established clinical research infrastructure with experienced investigators.

Predominantly European descent (Italian and Spanish heritage), making Argentina uniquely useful for trials needing Caucasian/European populations within a Latin American regulatory framework. Buenos Aires alone offers a vast pool of clinical sites with sophisticated medical infrastructure.

A unique mix of indigenous populations (Guna, Emberá), Afro-Caribbean communities, and mestizo groups. The Canal Zone historically attracted diverse immigration from Asia, the Caribbean, and Europe. Panama's compact geography and modern healthcare infrastructure make it efficient for multi-ethnic recruitment.

The second-largest Latin American country by population (130M+), with large mestizo and indigenous populations including Aztec, Maya, and Zapotec heritage communities. Mexico offers significant ethnic diversity combined with an extensive network of clinical research sites and experienced investigators across multiple therapeutic areas.

The most diverse country in Latin America and one of the most diverse in the world. Brazil has significant African, European, indigenous, and Asian (Japanese) ancestry — the country hosts the largest Japanese diaspora outside Japan. With 215 million people, Brazil offers unmatched scale and diversity for pivotal trial enrollment.

Strategic Country Selection for Your Diversity Action Plan

The key to a successful FDA Diversity Action Plan is matching your target diversity profile to the right Latin American country — or combination of countries. This requires understanding both the demographic landscape and the regulatory environment of each potential site.

• Define your target diversity profile based on FDA requirements and your device's intended patient population.
• bioaccess® helps match that profile to the right Latin American country or combination of countries with the strongest demographic fit.
• FIH and early feasibility data collected in Latin America can serve as a diversity "dry run" — validating recruitment strategies before your pivotal trial.
• Sites and investigators developed during the FIH phase can carry forward into pivotal studies, creating continuity and efficiency.

Target Population

Recommended Countries

Key Advantage

Indigenous / Mestizo

El Salvador, Mexico, Panama

High concentration of Mayan/Aztec/Guna heritage

African Descent

Dominican Republic, Colombia, Brazil

Large Afro-Caribbean and Afro-Latin populations

European Descent

Argentina, Brazil

Italian/Spanish heritage populations

Asian Ancestry

Brazil

Largest Japanese diaspora outside Japan

Maximum Diversity

Colombia, Brazil

All major ethnic groups in a single country

**🔗 From FIH to Pivotal: A Continuous Strategy**

By conducting your FIH study in a Latin American market with the right demographic profile, you're not just generating early clinical data — you're building the infrastructure for your pivotal trial's diversity strategy. Investigators, sites, and patient recruitment channels developed during the FIH phase become assets for your DAP submission.

How bioaccess® Supports Your Diversity Strategy

bioaccess® is the only Medtech-focused CRO in Latin America with the operational footprint and regulatory expertise to support FDA diversity requirements across multiple countries. Our services include:

• Country selection consulting based on your specific diversity targets and device indication.
• Site identification in communities with the required ethnic profiles — leveraging our network of 50+ pre-qualified clinical sites.
• Regulatory expertise across Panama, El Salvador, Colombia, Dominican Republic, Mexico, and other LATAM markets.
• End-to-end trial management from FIH through pivotal — ensuring continuity of your diversity strategy.
• FDA-accepted data quality: all trials conducted under ICH-GCP guidelines, compliant with 21 CFR 812.28.

**🏆 The bioaccess® Advantage**

With 50+ client companies served and 200+ companies consulted since 2010, bioaccess® has the deepest experience in Latin American medtech clinical trials. Our ACRP-certified clinical operations team ensures your diversity strategy is executed with the rigor and documentation that FDA expects.

Frequently Asked Questions

Does the FDA require patient diversity in medical device clinical trials?

Yes, under FDORA 2022, sponsors of pivotal clinical trials must submit Diversity Action Plans describing how they will enroll participants reflecting the demographics of the intended patient population. However, early-stage studies like FIH trials are not subject to these requirements.

Which Latin American countries offer the most diverse patient populations?

Brazil and Colombia are the most ethnically diverse, with significant African, indigenous, European, and (in Brazil) Asian populations. Dominican Republic has strong African heritage, El Salvador and Mexico have large indigenous populations, Argentina is predominantly European-descent, and Panama offers a unique mix of indigenous, Afro-Caribbean, and mestizo communities.

What is an FDA Diversity Action Plan (DAP)?

A DAP is a document required for pivotal trials that describes the demographic composition of the intended patient population, sets enrollment goals by race/ethnicity/sex/age, explains site selection rationale, and provides a plan to mitigate barriers to diverse enrollment.

Can FIH trial data from Latin America be used in a US pivotal trial?

Yes. Clinical data from Latin American sites is fully accepted by the FDA under 21 CFR 812.28, provided trials comply with ICH-GCP guidelines. Sponsors can strategically use FIH data as a foundation for their pivotal diversity strategy.

How can bioaccess® help with FDA diversity requirements?

bioaccess® is the only Medtech-focused CRO in Latin America and offers country selection consulting, site identification in communities with needed ethnic profiles, and regulatory expertise across Panama, El Salvador, Colombia, DR, Mexico, and other LATAM markets.

Take the Next Step

Ready to build your FDA diversity strategy? bioaccess® can help you identify the right Latin American markets, sites, and patient populations to support your pivotal trial enrollment goals — all while generating early clinical data through strategically designed FIH studies.

Ready to Build Your FDA Diversity Strategy?

Contact bioaccess® to discuss how Latin America's diverse patient populations can support your pivotal trial enrollment goals.

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