Where to Run Your First-in-Human Device Trial: U.S. vs Latin America

Choose a U.S. EFS when early, iterative FDA interaction is the priority — the agency shapes the device with you through the Pre-Sub and IDE cycle. Choose a Latin American FIH when activation speed and enrollment throughput are the binding constraints — and engineer the data from day one to come home under 21 CFR 812.28 (ISO 14155, independent ethics review, validatable data). Many sponsors do both in sequence.

Figures attributed; general information, not regulatory advice.

The seven geography criteria

Adapted from the EFS 10-year retrospective (Endovascular Today, May 2026): investigator access, infrastructure, EFS/FIH experience, recruitment and follow-up, clinical-trial insurance, cost, and data acceptance.

• Investigator access — Can the sites you need actually open an early study for a novel device?
• Infrastructure — Cath labs, imaging, and early-feasibility workflow experience for your device.
• EFS/FIH experience — Small, iterative studies run differently from large pivotal trials.
• Recruitment and follow-up — Enrollment throughput is often the binding constraint.
• Insurance — Clinical-trial insurance sized for a small early study; a known friction point at U.S. hospitals.
• Cost — The full study cost, not just per-patient headline numbers.
• Data acceptance — Whether the data can support your intended FDA pathway under 21 CFR 812.28.

Why sponsors choose a U.S. EFS

• Early, iterative FDA interaction — The agency shapes the device with you through the Pre-Sub and IDE cycle.
• U.S. site experience for later pivotal work — The operators who run your early study often train the pivotal sites.
• Investor and acquirer signaling — A signaling benefit, not a scientific one; price it accordingly.

Honest friction: hospital contracting timelines, clinical-trial insurance, and IRB costs slow U.S. EFS studies down (Endovascular Today, May 2026). The FDA's 30-day EFS IDE review target is a stated goal, not the whole timeline.

Why sponsors choose a Latin American FIH

• Activation speed and enrollment throughput — bioaccess's published planning ranges: 4–8 weeks for LATAM ethics review; typically 4–8 months protocol-to-first-patient via FIH-12™. Planning ranges, not guarantees.
• First data before the U.S. IDE spend — bioaccess's published planning ranges: $15K–$35K per patient LATAM FIH vs $40K–$75K U.S./EU benchmark. Planning ranges, not guarantees.
• Data engineered to come home — Designed from day one to ISO 14155 with independent ethics review and validatable data, supporting eligibility for FDA acceptance under 21 CFR 812.28. Acceptance is case by case, never automatic.

FDA acceptance of outside-U.S. data

Under 21 CFR 812.28, the FDA accepts outside-U.S. device data when: the study is run to ISO 14155 good clinical practice; an independent ethics committee reviews it; the FDA can validate the data through records access or inspection; and the data is applicable to the U.S. population. Acceptance is determined per submission — case by case, never automatic.

Hybrid sequences that work

• LATAM FIH, then U.S. EFS — De-risk the device first, then engage the FDA with human data in hand.
• U.S. EFS anchor, LATAM cohort in parallel — U.S. FDA interaction plus Latin American enrollment throughput.
• LATAM FIH straight to U.S. traditional feasibility — When the FIH data answers the FDA's early questions.

The decision matrix

Choose the U.S. when: early, iterative FDA interaction is the program's top priority; U.S. investigator and site experience matters for the later pivotal trial; the extra contracting time and per-patient cost fit your runway.

Choose Latin America when: activation speed and enrollment throughput are the binding constraints; you need first clinical data before committing to the cost of a U.S. IDE study; the study is engineered from day one to come home under 21 CFR 812.28.

The industry already runs early work outside the U.S.

An MDIC member survey found almost 53% of medtech respondents had initiated at least one EFS exclusively outside the U.S. in the prior two years — over half of those in Europe — while more than 60% said they were interested in trying EFS/FIH in the U.S. as a primary or parallel pathway. The industry wants both. (MDIC EFS/FIH report, 2024; member survey — illustrative, not a random sample.)

Frequently asked questions

Will the FDA accept my Latin American data?

It can — under 21 CFR 812.28, the FDA accepts data from device studies conducted outside the United States when the study is run to ISO 14155 good clinical practice, reviewed by an independent ethics committee, and the FDA can validate the data. Acceptance is determined per submission, case by case, never automatically.

Do I need a U.S. study to get FDA clearance?

No — there is no regulation requiring a U.S.-conducted study for FDA clearance or approval. What matters is that the data meets the applicable standards (ISO 14155 for devices), is applicable to the U.S. population, and is validatable by the FDA.

Which is faster: a U.S. EFS or a Latin American FIH?

In practice, a Latin American FIH typically reaches first patient sooner. bioaccess's published planning ranges are 4–8 weeks for LATAM ethics review and typically 4–8 months protocol-to-first-patient via FIH-12 — planning ranges, not guarantees.

Which is cheaper: a U.S. EFS or a Latin American FIH?

A Latin American FIH is typically the lower-cost path. bioaccess's published planning ranges put LATAM FIH at $15K–$35K per patient against a $40K–$75K U.S./EU benchmark — planning ranges, not guarantees.

Can I run in both geographies in sequence?

Yes — hybrid sequences are common: LATAM FIH then U.S. EFS; a U.S. EFS anchor with a parallel LATAM cohort; or LATAM FIH straight into U.S. traditional feasibility. The key is one regulatory strategy covering both geographies.

Does OUS data hurt my FDA submission?

No — the FDA evaluates the data's quality, not its geography. What hurts a submission is an OUS study that was never designed for FDA review: no ISO 14155 controls, weak monitoring, or data the FDA cannot validate.

When is a U.S. EFS the wrong choice?

When speed is the binding constraint and the device is not ready for the scrutiny of a Pre-Sub — or when the budget cannot absorb U.S. contracting, insurance, and per-patient costs.

When is Latin America the wrong choice?

When early, iterative FDA interaction is the program's top priority, or when the LATAM patient population or clinical practice cannot be shown applicable to the U.S. population, undermining 812.28 acceptance.

Primary sources

• Endovascular Today, May 2026 — The FDA EFS program: ideation through the first 10 years
• MDIC, 2024 — Clinical Trial Innovation and Reform: EFS/FIH study (member survey)
• FDA — Early Feasibility Study Program
• FDA EFS guidance (PDF) — IDEs for Early Feasibility Medical Device Clinical Studies
• CDRH Learn transcript — IDEs and early feasibility studies, including first-in-human studies
• eCFR — 21 CFR 812.28: acceptance of data from clinical investigations conducted outside the United States
• MDIC — Early feasibility studies

Related: FDA Early Feasibility Study Program · Early Feasibility Study IDE · FDA Acceptance of OUS Data · Early Feasibility Studies · U.S. Execution · First-in-Human CRO · Why U.S. Companies Run FIH Overseas