Latin America's ethnic diversity helps medtech sponsors meet FDA Diversity Action Plan requirements for pivotal trials — country-by-country demographic profiles and site selection strategy from bioaccess®.
March 23, 2026
6
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
In short
The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires Diversity Action Plans for Phase 3 drug studies and for device studies under an IDE or supporting a 510(k), De Novo or PMA — but only for studies that begin enrollment 180 days after FDA publishes final guidance. As of October 2026 that guidance is still a draft. Latin America brings together Indigenous, African-descent, European-descent, mestizo and Asian-descent communities across ICH-GCP countries, so sponsors can plan for representative enrollment from the first-in-human phase onward.
What Are FDA Diversity Action Plan Requirements?
The Food and Drug Omnibus Reform Act of 2022 (FDORA) added a statutory requirement for Diversity Action Plans (DAPs) covering Phase 3 (or other pivotal) drug studies and device studies that require an IDE or that support a 510(k), De Novo or PMA. The requirement takes effect only for studies that begin enrollment 180 days after FDA publishes final guidance. As of October 2026, FDA's June 2024 guidance remains a draft marked "Not for implementation," so no DAP submission is yet required. Sponsors planning pivotal studies should still build enrollment goals for the intended-use population into their protocols now, because the obligation will apply quickly once the guidance is final.
By statute, a DAP must include:
- The sponsor's enrollment goals, disaggregated by race, ethnicity, sex and age group of clinically relevant study populations.
- The sponsor's rationale for those goals.
- An explanation of how the sponsor intends to meet them. (Site selection and barrier mitigation are approaches described in the draft guidance, not separate statutory elements.)
**⚠️ Which studies are in scope?**
Once in effect, DAPs will apply to pivotal drug studies and to device studies under an IDE or supporting a 510(k), De Novo or PMA. Early feasibility and first-in-human device studies conducted under an IDE may fall within scope, so confirm applicability with FDA rather than assume FIH studies are exempt. Either way, sponsors can use Latin American FIH data as a foundation for their diversity strategy — see our FDA acceptance guide for Latin American first-in-human studies — developing sites, investigators, and patient recruitment pipelines that carry forward into the pivotal phase.
Why Does Latin America Offer a Diversity Advantage?
Latin America offers access to indigenous, African-descent, European, mestizo, and Asian communities across one ICH-GCP compliant region. This ancestral diversity is distributed across countries with established regulatory frameworks and experienced clinical investigators. For related guidance, read our Fitzpatrick skin type diversity in clinical trials guide.
A single CRO partner like bioaccess® can help sponsors access all of these populations through a coordinated, multi-country clinical strategy — an option that can offer competitive cost and timelines for many device programs. Each country's regulatory process remains separate.
**🌎 One region, broad representation**
Latin America brings together Indigenous (including Maya and Nahua) communities, Afro-Caribbean communities, European-descent cohorts, and Asian-descent groups across countries that follow ICH-GCP — a practical region for sponsors seeking broad patient representation. Show how your enrolled population maps to the US intended-use population rather than assuming it does.
What Are the Ethnic Profiles of Key LATAM Trial Countries?
Each Latin American country offers a distinct demographic profile. Understanding these differences allows sponsors to strategically select sites that match their DAP requirements.
Indigenous ancestry with Lenca, Maya and Nahua-Pipil 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.
How Should You Select Countries 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 Maya/Nahua/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 Can bioaccess® Support 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 100+ 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 (see our FDA acceptance guide for Latin American clinical data).
**🏆 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?
FDORA 2022 requires Diversity Action Plans for Phase 3 drug studies and for device studies under an IDE or supporting a 510(k), De Novo or PMA, but only for studies that begin enrollment 180 days after FDA publishes final guidance. As of October 2026 the June 2024 guidance is still a draft, so no plan is yet required. Separately, FDA already asks whether trial data apply to the US population.
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 plan required by FDORA (once FDA finalizes its guidance) that states the sponsor's enrollment goals by race, ethnicity, sex and age group, the rationale for those goals, and how the sponsor intends to meet them.
Can FIH trial data from Latin America be used in a US pivotal trial?
Yes. FDA accepts data from Latin American sites under 21 CFR 812.28 when the study is well designed, well conducted, GCP-compliant and verifiable by FDA. 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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