PRACTICAL GUIDE | 2026
The most-asked question in offshore FIH — answered with the actual regulation.
By Julio G. Martinez-Clark
CEO, bioaccess®
Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.
Will the FDA accept data from a Latin American first-in-human trial? It is the single most-asked question in our offshore FIH practice. Sponsors ask it in nearly identical words on almost every first call: “Do I have to present this data to the FDA?… what approval do I need before doing that?” A US medtech sponsor once told us he feared an IDE rejection of “South American” data outright. Our answer then and now: that is not an issue at all — provided the study is run to the standard FDA actually asks for.
First, the definitions. FIH means first-in-human: the first time a device or drug is tested in people. GCP means good clinical practice — the international quality standard for designing, conducting, recording, and reporting clinical investigations so the data are credible and subjects are protected (ICH E6; ISO 14155 for medical devices). An IDE is a US investigational device exemption, the FDA permission to study a significant-risk device in humans.
What does the FDA actually require for foreign clinical data?
The rule for medical devices is 21 CFR 812.28, “Acceptance of data from clinical investigations conducted outside the United States.” FDA will accept information on an outside-the-US investigation to support an IDE or a device marketing application — a PMA, a 510(k), or a De Novo request — if the investigation was well designed and well conducted and specific conditions are met. The headline condition is a statement that the investigation was conducted in accordance with GCP, defined as a standard for design, conduct, performance, monitoring, auditing, recording, analysis, and reporting that provides assurance the data and results are credible and accurate and that subjects’ rights, safety, and well-being are protected. GCP includes prior and continuing review and approval by an independent ethics committee (IEC) — what US sponsors call an IRB — and documented, freely given informed consent. The sponsor must ensure FDA is able to validate the data, including by on-site inspection if the agency deems it necessary, and must supply supporting information on the investigators, the protocol, and how GCP compliance was achieved.
For drugs and biologics, the parallel rule is 21 CFR 312.120: FDA accepts foreign clinical studies not conducted under a US IND when they meet GCP requirements. The principle is the same across product types.
Does the FDA prefer data from some countries over others?
No. Sponsors sometimes assume FDA quietly discounts data from smaller or less familiar markets — Panama, El Salvador, the Dominican Republic. In practice, FDA has no published preference list and no country-level bar. The review question is always site-level: was this a qualified site, run by a trained investigator under an independent ethics committee, with GCP documentation FDA can audit? FDA’s scrutiny of any foreign dataset is the same wherever it comes from — GCP compliance, verifiability, and applicability of the study population and clinical practice to the United States. Choose countries by speed, cost, recruitment, and investigator quality. Do not choose them for a supposed “data prestige” ranking that does not exist in the regulation.
Do I have to present this data to the FDA?
Not necessarily. Many Latin American FIH studies are run for internal decision-making: prove the concept works in humans, learn how the device behaves, fix the design or the protocol. If the data never enter a US submission, there is no obligation to present them to the FDA. Early FIH data de-risk the FDA path instead: sponsors arrive at a pre-submission meeting or an IDE with real human evidence rather than assumptions. As Julio tells sponsors, “99% of our clients, they use the data” — and he has never seen FDA reject data because of the country where it was generated. Never. Never, never.
How do LATAM/US data splits work in pivotal studies?
When a pivotal program will run partly in Latin America and partly in the United States, the split is negotiated with FDA — it is “not a black-and-white answer.” Sponsors commonly discuss allocations such as 70–30, 80–20, or 50–50 between regions, typically in a pre-submission (Q-sub) meeting before the pivotal protocol is finalized. FDA wants assurance that the data support the US intended-use population, which is why the conversation happens up front, with the full FIH and feasibility record on the table.
| Split model | Typical shape | When sponsors use it |
|---|---|---|
| LATAM-heavy (70–30) | Most enrollment in Latin America; US cohort confirms generalizability | FIH and feasibility already completed in LATAM; device is stable |
| Balanced (50–50) | Roughly equal enrollment | Sponsor wants parallel recruitment and a single global dataset |
| US-heavy (80–20) | Most enrollment in the US; LATAM sites add speed and diversity | Sponsor plans a US-led IDE with regional acceleration |
The point: the split is a negotiation with FDA, not a dictate. Bring the question early and bring the data.
How do you de-risk FDA acceptance before the study starts?
- Confirm the protocol, monitoring plan, and data management meet ISO 14155 (devices) and ICH-GCP from day one — not as a retrofit before submission.
- Qualify investigators and sites against FDA-inspectable standards: training records, delegation logs, device accountability, source documentation.
- Document independent ethics-committee review and informed consent per GCP as defined in 21 CFR 812.28(a)(1).
- Build the inspectable file from the first patient, not the last. Our companion post, “What FDA Reviewers Actually Open After a LATAM Device FIH: The ISO 14155 Inspectable File,” covers that file’s mechanics; this post covers the acceptance question it serves.
- Consider an FDA pre-submission to align on the FIH study’s role in the IDE, 510(k), De Novo, or PMA strategy — especially before locking a pivotal data split.
Frequently asked questions
Q: Can I use Latin American FIH data in an IDE submission?
A: Yes — 21 CFR 812.28 expressly provides for FDA acceptance of outside-the-US device investigations supporting an IDE, when the study was well designed, GCP-compliant, and the data are credible and verifiable.
Q: What if my LATAM study was not fully GCP-compliant?
A: FDA allows a waiver request under 21 CFR 812.28(c), or a statement explaining the reason for noncompliance plus steps taken to ensure the data are credible and subjects were protected. Treat that as a fallback, not a plan: design for GCP from day one.
Q: Does FDA inspect Latin American sites?
A: FDA may validate foreign data through on-site inspection if it deems it necessary — and the sponsor must ensure that is possible. Build the site file as if an inspection is coming: that is the practical premise of the acceptance rule.
Q: Will FDA accept data from Panama, El Salvador, Colombia, or Brazil specifically?
A: The regulation sets no country-specific bar. FDA has never, to our knowledge, rejected data because of the Latin American country where it was generated. Site qualification and GCP compliance decide.
Q: Is GCP-compliant LATAM data usable in Europe or other regions too?
A: ICH-GCP is the international standard, so a GCP-compliant package is generally usable across regulators — but each region has its own submission rules. Confirm the strategy with regulatory counsel for every target market.
Q: Will the FDA accept data from a Latin American first-in-human trial run at two sites in two countries?
A: Yes, under the same conditions — multi-site, multi-country data are routine. Keep the GCP standard identical across sites and document any country-level differences in ethics or import processes.
Will the FDA accept data from a Latin American first-in-human trial? The evidence says yes — routinely, for years — when sponsors hold the study to the standard FDA wrote into the regulation. Geography is not the risk. Sloppy GCP is.
Talk with bioaccess® about your Latin America FIH strategy
If you are weighing a Latin American first-in-human and want to know how the data would slot into your FDA strategy — IDE, 510(k), De Novo, or PMA — we will walk through it with you before you spend anything.
Talk with bioaccess® about your Latin America FIH strategy
References
- 21 CFR 812.28 — Acceptance of data from clinical investigations conducted outside the United States (medical devices).
- 21 CFR 312.120 — Foreign clinical studies not conducted under an IND (drugs and biologics).
- FDA guidance: “Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions” — https://WWW.FDA.GOV/media/111346/download
- bioaccess® operational experience with LATAM FIH studies and FDA submissions, 2021–2026. Last verified: September 2026.
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