FDA Acceptance: LATAM First-in-Human Guide

Three questions every MedTech sponsor asks before launching a First-in-Human study in Latin America — and the detailed answers, with a sourced list of companies that used Latin American clinical data with FDA.

Last updated: October 16, 2026

45

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

FDA

Clinical Trials

Latin America

First-in-Human

Regulatory

Colombia

Preclinical Testing

ISO 14155

21 CFR 812.28

In short

Yes — the FDA accepts Latin American first-in-human data under 21 CFR 812.28 for devices and 21 CFR 312.120 for drugs and biologics, when studies are GCP-compliant, IEC-approved, and use the submission device. This guide answers the three questions every MedTech sponsor asks before launching a LATAM FIH study, with regulatory precedent, case studies, and preclinical requirements.

Does the FDA Accept Clinical Data from Latin America?

Yes — unequivocally. The FDA explicitly accepts clinical data from investigations conducted outside the United States. This is codified in 21 CFR § 812.28, which states that the FDA will accept foreign clinical data to support an Investigational Device Exemption (IDE), 510(k), De Novo, Pre-Market Approval (PMA), or Humanitarian Device Exemption (HDE) submission — provided three conditions are met. For the broader framework, see our FDA acceptance guide for Latin American clinical data:

• The study was conducted in accordance with Good Clinical Practice (GCP).
• The study was reviewed and approved by an Independent Ethics Committee (IEC).
• The device used in the study is identical — or adequately compared — to the device being submitted in the United States.

Section 812.28(e) further states that even when a foreign study does not fully meet all conditions, the FDA may still accept the data if it finds the results credible and that patient rights were adequately protected.

Parallel regulations confirm this across product categories: 21 CFR § 312.120 governs the acceptance of foreign clinical data for drugs and biologics, while 21 CFR § 814.15 specifically addresses the acceptance of foreign data in PMA applications for medical devices.

**⚖️ This is not a workaround — it is the FDA's intended pathway.**

The regulatory framework was designed so that high-quality clinical evidence generated anywhere in the world can support U.S. market authorization. Latin America's regulatory systems, clinical infrastructure, and GCP-compliant investigators make it one of the most effective regions to execute this strategy.

Which Companies Have Used Latin American Clinical Data in FDA Submissions?

Prospects ask us this on almost every first call: has any company actually used clinical data from Latin America in a U.S. Food and Drug Administration (FDA) submission? Yes. FDA's own review documents name Chile, Brazil, Panama and the Dominican Republic as sources of clinical data behind device approvals. FDA drug and vaccine labels name Argentina, Bolivia, Brazil, Colombia, Mexico and Peru. This page lists those companies and links each one to a primary source: an FDA document, a U.S. Securities and Exchange Commission (SEC) filing, a ClinicalTrials.gov record, a peer-reviewed paper or the company's own press release.

It also answers the more useful question. Which FDA step did the Latin American data support? The answer varies. Some datasets were the pivotal evidence for approval. Others were supporting feasibility data in a premarket approval file. Others got a program to an investigational device exemption, and that is a different milestone from approval.

Key terms used on this page

• FIH (first-in-human): the first study of a device or drug in people.
• EFS (early feasibility study): a small early device study used to refine the design and procedure.
• Pivotal study: the main study designed to show a device is safe and effective for its intended use.
• IDE (investigational device exemption): FDA permission to run a significant-risk device study in the United States. An IDE is not a marketing authorization.
• PMA (premarket approval): FDA's approval pathway for most Class III (highest-risk) devices.
• De Novo: FDA's pathway for novel low-to-moderate-risk devices with no existing predicate.
• 510(k) (premarket notification): clearance based on substantial equivalence to a legally marketed device.
• SSED (Summary of Safety and Effectiveness Data): FDA's public summary of the evidence behind a PMA approval.
• OUS (outside the United States): FDA's term for clinical data generated in other countries.
• NDA (new drug application) and BLA (biologics license application): marketing applications for drugs and for vaccines and other biologics.
• GCP (good clinical practice): the international quality standard for running clinical studies. For devices, ISO 14155 is the GCP standard.
• INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos): Colombia's national regulator.

The short answer

FDA accepts clinical data from outside the United States when the study meets its conditions. For devices, the rule is 21 CFR 812.28 (data supporting an IDE, 510(k), De Novo or PMA), with 21 CFR 814.15 for PMAs. For drugs and biologics, it is 21 CFR 312.120. None of these rules ranks countries. They ask whether the study followed GCP, was reviewed by an independent ethics committee, and produced data FDA can verify, including by inspection. For the regulation itself, see our guide to whether FDA accepts data from a Latin American first-in-human trial and our page on 21 CFR 812.28 inspectability.

The public record shows Latin American data in three roles:

1. Pivotal evidence for marketing authorization. Examples: the Levita Magnetic Surgical System (Chile, De Novo) and several drugs and vaccines, including two Chagas disease treatments whose pivotal trials ran only in Latin America.
2. Part of a multinational pivotal study. Examples: TriVascular's Ovation stent graft (Chile) and Pulmonx's Zephyr valves (Brazil).
3. Supporting early clinical data. FIH or feasibility studies that FDA summarized as supplemental information in a PMA, or that sponsors used to reach an IDE. Examples: VenaSeal and both Optilume devices (Dominican Republic, Panama), ReGelTec and enVVeno (Colombia).

Medical devices: FDA documents that name Latin American clinical data

Each row below comes from FDA's own decision summary or SSED. Under the FDA step column, "supplemental" means FDA summarized the Latin American study as supporting information and the pivotal study ran elsewhere.

Company

Device

Country

Latin American study

FDA step and outcome

FDA source

Levita Magnetics

Magnetic Surgical System (laparoscopic cholecystectomy)

Chile

Feasibility (21 patients) and pivotal (50 patients) at three Santiago sites

De Novo DEN150007, granted June 13, 2016. The pivotal data were from Chile

FDA De Novo decision summary

TriVascular (now Endologix)

Ovation Abdominal Stent Graft System

20 of 161 pivotal patients (U.S., Germany, Chile)

PMA P120006, approved October 5, 2012

SSED P120006

Pulmonx

Zephyr Endobronchial Valve

Brazil

LIBERATE pivotal trial sites in the U.S., UK, Brazil and the Netherlands

PMA P180002, approved June 29, 2018. FDA states the LIBERATE data "were the basis for the PMA approval decision"

SSED P180002

Sapheon (now Medtronic)

VenaSeal Closure System

Dominican Republic

Feasibility study, 38 patients, La Romana

PMA P140018, approved February 20, 2015. Supplemental; the pivotal study (VeClose) was in the U.S.

SSED P140018

Urotronic

Optilume Urethral Drug-Coated Balloon

Panama, Dominican Republic

ROBUST I first-in-human study, 53 patients, four centers

PMA P210020, approved December 3, 2021. Supplemental; the pivotal study was ROBUST III

SSED P210020

Optilume BPH Catheter System

EVEREST-I pilot study, 80 patients, six sites

PMA P220029, approved June 30, 2023. Supplemental; the pivotal study was PINNACLE

SSED P220029

Two points stand out. First, Latin American data appear in every major device pathway: De Novo, PMA pivotal and PMA supplemental. Second, FDA documents identify the data by study and site. The value of the data comes from how the study was run and documented, not from the country's name.

Two Colombia programs prospects ask about: ReGelTec and enVVeno

Both claims came up in a recent prospect conversation. We checked each against primary sources. The details matter because each program used its Colombian data for an IDE-stage step, not for approval.

ReGelTec (HYDRAFIL® System): Colombia early feasibility data, then an FDA IDE

In October 2019, ReGelTec announced it had chosen Colombia and bioaccess® as its CRO (contract research organization) for the first-in-human study of HYDRAFIL, an injectable hydrogel for chronic low back pain from degenerative disc disease, at Centro Médico Cediul in Barranquilla. The company reported that 20 patients were treated in that early feasibility study between August and December 2020. Peer-reviewed results were published in the Journal of Vascular and Interventional Radiology.

The FDA steps, in the company's words:

• December 2020: ReGelTec announced FDA Breakthrough Device designation. The same announcement reported the Colombia study's 20 patients. The company did not say the designation was based on those data, so we don't say it either.
• September 2023: ReGelTec announced FDA approval of an IDE for HYDRAFIL-D, its U.S. pivotal study. Its CEO said that "once we were able to share the 1-year follow-up data on our first sixty patients with the FDA, the team was able to work with the agency to obtain IDE approval." A peer-reviewed 60-patient feasibility cohort enrolled in Canada and Colombia was later published in Pain Physician.
• June 2025: ReGelTec reported treating the first patient in the HYDRAFIL-D IDE trial. HYDRAFIL is limited by U.S. law to investigational use.

What the record supports: Colombian early feasibility data were part of the clinical record ReGelTec shared with FDA to obtain IDE approval for its pivotal study. They were not data in a marketing application.

enVVeno Medical (VenoValve®): a Colombian first-in-human study, an IDE, and a PMA that was not approved

enVVeno Medical, formerly Hancock Jaffe Laboratories, describes the program in its SEC filings. After consulting FDA, it ran an 11-patient first-in-human study of the VenoValve, a surgically implanted bioprosthetic venous valve, in Colombia. INVIMA approved the study in December 2018, and implants took place in Bogotá between February and December 2019. The company presented the first-in-human results at a pre-IDE meeting with FDA in January 2021. It filed the IDE in March 2021, with pivotal endpoints that it said "mirror those endpoints used for the first-in-human trial", and received IDE approval that month for the U.S. SAVVE pivotal study. Follow-up from the Colombian cohort was published at one, two and three years.

The PMA rested on SAVVE, which enrolled patients only at U.S. sites. enVVeno filed the PMA in November 2024. In its 2025 annual report, the company disclosed that it received a not-approvable letter from FDA on August 19, 2025, and that its supervisory appeal was denied on November 13, 2025.

What the record supports: Colombian first-in-human data helped enVVeno design and justify a U.S. pivotal study under an IDE. Approval depended on the U.S. pivotal data, and FDA did not approve the PMA. Early Latin American data can speed the path to an IDE. They do not replace the pivotal evidence FDA uses to decide approval.

Drugs and vaccines: FDA labels that name Latin American trials

For drugs and biologics, the clearest public evidence is the FDA-approved label (prescribing information). Its clinical studies section often names the countries where the pivotal trials ran.

Product

Latin American countries named

Role of the data

FDA outcome

Source

Chemo Research / Exeltis

Benznidazole (Chagas disease)

Argentina, Brazil

Both placebo-controlled pivotal trials in children

NDA, accelerated approval, 2017

FDA label (DailyMed)

Bayer

Lampit (nifurtimox, Chagas disease)

Argentina, Bolivia, Colombia

The single pivotal trial (CHICO)

NDA approved, 2020

FDA label (DailyMed)

GSK

Krintafel (tafenoquine, P. vivax malaria)

Brazil, Peru

Most patients in the pivotal trial were from Latin America

NDA approved, 2018

FDA label (DailyMed)

Rotarix (rotavirus vaccine)

11 Latin American countries

Pivotal efficacy and intussusception safety study (with Finland)

BLA approved, 2008

FDA label (DailyMed)

Sanofi

Dengvaxia (dengue vaccine)

Brazil, Colombia, Honduras, Mexico

Pivotal efficacy study CYD15 (with Puerto Rico)

BLA approved, 2019

FDA Summary Basis for Regulatory Action

Takeda

TAK-003 (dengue vaccine)

Brazil, Colombia, Dominican Republic, Nicaragua, Panama

Pivotal efficacy study TIDES (with Asian sites)

BLA submitted; Takeda withdrew it in July 2023 over data-collection questions

Takeda statement

Gilead Sciences

Truvada for HIV pre-exposure prophylaxis (PrEP)

Brazil, Ecuador, Peru

Pivotal iPrEx trial (with U.S., South Africa, Thailand)

Supplemental NDA approved, 2012

ClinicalTrials.gov NCT00458393

ViiV Healthcare

Apretude (cabotegravir PrEP)

Argentina, Brazil, Peru

Pivotal HPTN 083 trial; label reports a Latin America subgroup

NDA approved, 2021

FDA label (DailyMed)

Yeztugo (lenacapavir PrEP)

Argentina, Brazil, Mexico, Peru

Pivotal PURPOSE 2 trial

NDA approved, 2025

FDA label (DailyMed)

Pfizer / BioNTech

Comirnaty (COVID-19 vaccine)

Pivotal Phase 1/2/3 study sites

BLA approved, 2021

FDA label (DailyMed)

The TAK-003 row is included on purpose. Running a pivotal trial in Latin America does not guarantee an approval. FDA questioned what the protocol had collected, not where it was collected.

What this means for a device sponsor planning a Latin American study

• Decide the FDA use before choosing the country. An FIH study meant to inform an IDE needs different planning than a pivotal cohort meant for a PMA. Our article on using OUS first-in-human data for an IDE covers the difference.
• Talk to FDA early. enVVeno presented its first-in-human results at a pre-IDE meeting. A Q-Submission is where the role of Latin American data gets agreed.
• Build the file FDA will read. FDA documents describe Latin American studies by protocol, sites, endpoints and follow-up. GCP and ISO 14155 records, ethics committee approvals and the national regulator's authorization (such as INVIMA in Colombia) are what make the data usable.
• Plan for applicability to U.S. patients. When Latin American patients are part of a pivotal dataset, FDA looks at whether the results apply to the U.S. population and U.S. clinical practice. That conversation belongs before enrollment, not after.
• Keep the milestones straight. Breakthrough designation, an IDE, and a PMA or De Novo decision are different events. Report each one as what it is.

Planning a first-in-human or early feasibility study in the region? See how bioaccess® runs device studies in Colombia and in other Latin American countries, or contact our team.

How to check a claim yourself

• For a PMA device, open the SSED from FDA's PMA database and read the clinical studies and "supplemental clinical information" sections.
• For a De Novo device, open the decision summary from FDA's De Novo database and read the clinical information table.
• For a public company, search its 10-K filings on SEC EDGAR for the country name and "first-in-human".
• For any trial, check the location list on ClinicalTrials.gov. Some early Latin American device studies are not registered there.
• For a drug or vaccine, read section 14 (Clinical Studies) of the FDA label on DailyMed.

Sources

#

Type

1

FDA

De Novo decision summary DEN150007, Levita Magnetic Surgical System

2

SSED P120006, Ovation Abdominal Stent Graft System

3

SSED P180002, Zephyr Endobronchial Valve System

4

SSED P140018, VenaSeal Closure System

5

SSED P210020, Optilume Urethral Drug-Coated Balloon

6

SSED P220029, Optilume BPH Catheter System

7

ReGelTec: CRO and Colombia site selection (Oct 2019)

8

ReGelTec: Breakthrough Device designation (Dec 2020)

9

ReGelTec: FDA approves IDE for HYDRAFIL-D (Sept 2023)

10

Peer-reviewed

Beall et al., J Vasc Interv Radiol 2024 (HYDRAFIL early feasibility study)

11

Clerk-Lamalice et al., Pain Physician 2025 (60-patient cohort, Canada and Colombia)

12

SEC

enVVeno (Hancock Jaffe) Form 10-K for 2020: Colombia FIH, pre-IDE meeting, IDE filing

13

enVVeno Form 10-K for 2025: PMA not-approvable letter and appeal decision

14

Ulloa et al., J Vasc Surg Venous Lymphat Disord 2021 (VenoValve FIH, Bogotá)

15

ClinicalTrials.gov

NCT04943172, SAVVE U.S. pivotal study

16

FDA label

Benznidazole prescribing information

17

Lampit prescribing information

18

Krintafel prescribing information

19

Rotarix prescribing information

20

Dengvaxia Summary Basis for Regulatory Action (May 2019)

21

NCT01374516, Dengvaxia CYD15 study (Brazil, Colombia, Honduras, Mexico, Puerto Rico)

22

Takeda: withdrawal of U.S. BLA for TAK-003 (July 2023)

23

NCT00458393, iPrEx

24

Apretude prescribing information

25

Yeztugo prescribing information

26

Comirnaty prescribing information

27

Regulation

21 CFR 812.28, acceptance of data from clinical investigations conducted outside the United States

28

21 CFR 312.120, foreign clinical studies not conducted under an IND

This page summarizes public regulatory, SEC, registry and peer-reviewed records as of October 15, 2026. It is general information, not legal or regulatory advice. Product names are trademarks of their owners. Investigational devices are limited by U.S. law to investigational use.

What Are the Regulatory Requirements for a Clinical Study in Latin America?

Each country has its own national regulatory authority and Independent Ethics Committees, but the general framework is consistent across the region.

bioaccess® manages the entire submission process end-to-end — from protocol alignment and ethics committee preparation to national regulatory authority notification and site readiness — in whichever Latin American country is selected for the study.

**National authorization, not an FDA IDE**

Each Latin American country runs its own national authorization of the clinical investigation through its regulator and ethics committees. An FDA IDE is the U.S. authorization that lets an investigational device be shipped and studied in the United States (21 CFR 812.1(a)); a study run only at Latin American sites does not need one. FDA can still accept the foreign data later under 21 CFR 812.28 when its conditions are met.

Approval timelines vary by country, ethics committee and dossier completeness.

**🌎 bioaccess® Regional Presence**

bioaccess® has active operations and clinical site partnerships across multiple countries in Latin America, including Colombia, Brazil, Mexico, Panama, Argentina, Chile, and others.

Key Submission Requirements

• Study Protocol (ISO 14155-compliant)
• Investigator Brochure (IB) with complete preclinical and device data
• Informed Consent Documents (translated and culturally adapted for the local population)
• Ethics Committee Application & supporting dossier
• National Regulatory Authority notification of the clinical investigation
• Site Qualification documentation (facility, staff credentials, equipment)
• GCP Compliance — documentation that the study will adhere to ISO 14155:2020

bioaccess® handles all regulatory submissions, ethics committee interactions, site management, clinical monitoring, and data management — giving sponsors a single point of accountability for the entire study, regardless of country.

What Preclinical and Bench Testing Is Required Before a First Feasibility Study?

Before enrolling a single patient in a first-in-human clinical study, sponsors must assemble a comprehensive preclinical and bench testing package that demonstrates device safety. Below is the typical testing framework organized by category:

3.1 Biocompatibility Testing (ISO 10993 Series)

• Cytotoxicity testing
• Sensitization testing
• Irritation testing
• Acute systemic toxicity
• Pyrogenicity testing
• Implantation studies — short-term and long-term
• Hemocompatibility testing
• Histopathological analysis

3.2 Materials Characterization

• Chemical characterization of device materials
• Degradation studies — in vitro and in vivo, especially for biodegradable components

3.3 Performance and Bench Testing

• Functional performance verification
• Mechanical performance testing
• Delivery system reliability
• Injection and deployment testing
• Dimensional control and conformity testing

3.4 Sterility and Packaging

• Sterilization process validation (per ISO 11137-1)
• Packaging integrity testing (ISO 11607-1/2, ASTM F88/F1886)
• Shelf-life and accelerated aging studies supporting the labeled shelf life

3.5 Animal and Preclinical Efficacy Studies

• Small animal models (rodent) for proof-of-concept
• Large animal models chosen for the device and anatomy (for example porcine or ovine models)
• Functional outcomes, histology, and imaging correlation

3.6 Risk Management

Preliminary Hazard Analysis or a full Risk Management File per ISO 14971, documenting identified hazards, risk estimation, risk evaluation, and risk control measures.

3.7 GMP and Manufacturing

• Evidence of GMP-compliant manufacturing and design controls for the investigational device — typically a signed GMP / quality-system attestation, or a GMP certificate where the country or importer asks for one
• ISO 13485 certification is not a mandatory document for an investigational device in the country trial regulations we reviewed; some countries ask for a GMP certificate at import

See our guide GMP attestation vs ISO 13485 certificate for LATAM first-in-human trials for country-by-country requirements.

In the U.S., an IDE likewise exempts the investigational device from the quality management system regulation except design controls (21 CFR 812.1(a), 820.10(c)); the IDE asks for a description of manufacturing methods and controls (812.20(b)(3)), not an ISO 13485 certificate.

3.8 Investigator Brochure

A comprehensive document summarizing all preclinical data, device description, risk-benefit analysis, and proposed clinical use. The Investigator Brochure (IB) is the central document reviewed by Ethics Committees and regulatory authorities.

What Is the FDA Regulatory Framework for Foreign Device Data?

The legal authority governing FDA's acceptance of clinical data from outside the United States for medical devices is 21 CFR § 812.28 — "Acceptance of Data from Clinical Investigations Conducted Outside the United States." This regulation establishes a clear, structured framework that allows sponsors to use foreign clinical data to support virtually any FDA marketing submission.

Understanding this framework in detail is essential for any sponsor planning to use Latin American clinical data in an FDA submission. The regulation is not merely permissive — it is designed to facilitate the global development of medical devices while maintaining rigorous standards for patient safety and data integrity.

Core Acceptance Criteria Under 21 CFR 812.28(a)

Under 21 CFR 812.28(a), FDA will accept information on a clinical investigation conducted outside the United States to support an IDE or a device marketing application or submission (PMA, HDE, 510(k) or De Novo) if the investigation is well-designed and well-conducted and the following conditions are met:

• 812.28(a)(1) — A statement is provided that the investigation was conducted in accordance with good clinical practice (GCP). GCP includes review and approval (or a favorable opinion) by an independent ethics committee (IEC) before the investigation starts, continuing IEC review, and freely given informed consent obtained and documented before the investigation starts.
• 812.28(a)(2) — The supporting information in 812.28(b) is submitted: all of it for a significant risk device; for a non-significant risk device, items (b)(1), (4), (5), (7)–(9) and (11), with (b)(10) and the risk rationale available on request; for an investigation exempt under 812.2(c), items (b)(1), (4), (5) and (7)–(11), plus the rationale for the exemption, are made available on request.
• 812.28(a)(3) — FDA is able to validate the data from the investigation through an onsite inspection, or through other appropriate means, if the agency deems it necessary.

The 812.28(b) supporting information includes: investigator names and the sites where records are kept (b)(1); investigator qualifications (b)(2); a description of the research facilities (b)(3); a detailed summary of the protocol and results (b)(4); a statement that the device is identical to the submission device, or a detailed comparison (b)(5); for safety and effectiveness claims, a discussion showing the data are valid scientific evidence under 21 CFR 860.7 (b)(6); the IEC's name and address and a statement that it meets 812.3(t) (b)(7); a summary of the IEC decision (b)(8); how informed consent was obtained (b)(9); any subject incentives (b)(10); how the sponsor monitored the investigation (b)(11); and how investigators were trained in GCP and the protocol (b)(12).

The Flexibility Provision: 21 CFR 812.28(e)

21 CFR 812.28(e) covers foreign investigations that do not meet the conditions in 812.28(a): FDA may still accept that information to support an IDE or a device marketing application or submission if FDA believes the data and results are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected. Separately, 812.28(c) lets a sponsor ask FDA to waive requirements of 812.28(a)(1) and (b).

**Why 812.28(e) Matters for Sponsors**

This flexibility provision means that even if a minor procedural deviation occurred during a LATAM trial, the FDA retains discretion to accept the data based on overall quality and scientific merit. This is not a loophole — it reflects FDA's pragmatic approach to global clinical evidence. However, sponsors should always design for full 812.28(a) compliance and treat 812.28(e) as a safety net, not a primary strategy.

GCP Definition for Device Investigations

For purposes of 21 CFR 812.28, Good Clinical Practice (GCP) is defined by alignment with multiple standards:

• ICH E6(R3) — The current ICH Good Clinical Practice guideline (ICH Step 4, January 2025; issued as FDA guidance by CDER/CBER, September 2025; ISO 14155 is the device-specific GCP standard), covering investigator and sponsor responsibilities, IEC review, and risk-proportionate quality management.
• ISO 14155:2020 — The international standard specifically for clinical investigation of medical devices. This is the most relevant GCP standard for device trials and is explicitly referenced by FDA in its guidance documents.
• 21 CFR 312.120 — While primarily applicable to drugs, this regulation provides additional GCP definitions that FDA applies by analogy to device investigations.

**⚠️ Critical Date: February 21, 2019**

Clinical investigations initiated on or after February 21, 2019 must conform to GCP as described in FDA's 2018 guidance document "Acceptance of Clinical Data to Support Medical Device Applications and Submissions." Investigations initiated before this date are evaluated under prior standards, but sponsors are encouraged to meet the current GCP requirements regardless of start date.

How Is ISO 14155:2020 Implemented in Latin American Trials?

ISO 14155:2020 — "Clinical investigation of medical devices for human subjects — Good clinical practice" — is the internationally recognized gold standard for conducting medical device clinical investigations. For sponsors planning to use Latin American data in FDA submissions, designing trials in conformance with ISO 14155 is the single most effective strategy to demonstrate GCP compliance.

ISO 14155:2020 is an FDA-recognized consensus standard (recognition no. 2-282), and conformance helps a sponsor document GCP, but 21 CFR 812.28 sets its own conditions: a GCP statement (including IEC review and informed consent), the supporting information in 812.28(b), and data FDA can validate (21 CFR 812.28). Plan the dossier against those paragraphs directly.

Core Requirements of ISO 14155

Country-Specific Regulatory Considerations

While ISO 14155 provides the overarching framework, each Latin American country has specific regulatory requirements that must be layered on top. The strategic approach is to design one protocol that satisfies the most stringent requirements across all planned countries, plus ISO 14155, plus FDA expectations.

Brazil (ANVISA / CONEP)

Governed by RDC 630/2022, Brazil requires ANVISA authorization and CONEP (national ethics commission) review for device clinical investigations. Brazil has the most complex regulatory pathway in LATAM but also the largest patient population.

Mexico (COFEPRIS)

COFEPRIS requires a clinical trial authorization. Mexico offers a large, diverse patient population with significant clinical research infrastructure. Ethics committee review runs in parallel with COFEPRIS authorization.

Colombia (INVIMA)

bioaccess® recommends Colombia for drug, biologic, and vaccine trials. Resolución 8430 de 1993 articles 53 and 54 cover medicines and biological products from Phase I through Phase IV, and Resolución 2378 de 2008 article 5 requires INVIMA approval or prior visto bueno before that project starts. This page does not publish a day-count. Headquarters are in Miami. For a medical device clinical trial — first-in-human, early feasibility, or pivotal — bioaccess® leads with Panama, El Salvador, Chile, Costa Rica, and the Dominican Republic.

Argentina (ANMAT)

Argentina has modernized its clinical-research framework in recent years, with ANMAT operating risk-stratified approval tracks, parallel ethics review, and adoption of ICH E6(R3) Good Clinical Practice standards. ANMAT became a full ICH Regulatory Member in June 2024, and its current regime establishes dedicated Phase I / first-in-human center accreditation requirements. Argentina offers strong academic medical centers and experienced clinical investigators, particularly in cardiovascular and orthopedic indications.

**🎯 Strategic Approach: Design for Maximum Compliance**

The most effective strategy is to design a single protocol that meets the highest common denominator across all target countries, ISO 14155:2020, and FDA expectations. This eliminates the need for country-specific protocol amendments and ensures the data package is immediately usable for any regulatory pathway globally.

How Do You Build FDA Acceptance Into Your LATAM Trial Design?

The key to a successful LATAM-to-FDA strategy is proactive design — building FDA acceptance into every aspect of the trial from the earliest planning stages. Sponsors who treat LATAM trials as "separate from" the FDA strategy often face costly remediation later. The following framework ensures your LATAM trial produces data that FDA will find compelling.

Pre-Submission Strategy: The Q-Sub Program

Before finalizing your LATAM trial protocol, consider engaging with FDA through the Q-Submission (Q-Sub) Program, also known as the Pre-Submission (Pre-Sub) Program. This is one of the most valuable and underutilized tools available to device sponsors.

• A Q-Sub allows you to present your proposed LATAM trial design to FDA and receive written feedback on a timeline that varies by study (we confirm it per protocol).
• There is no user fee for Q-Submissions — they are free.
• You can ask FDA specific questions about your protocol design, endpoint selection, statistical analysis plan, and whether LATAM data will be acceptable for your intended submission pathway.
• FDA's written feedback from a Pre-Sub is not binding, but it provides invaluable directional guidance and creates a documented record of FDA's expectations.
• If appropriate, you can request a meeting with the review division (typically a teleconference) to discuss your questions in detail.

**💡 bioaccess® Recommendation**

We strongly recommend that all sponsors planning to use LATAM data for FDA submissions file a Q-Sub before finalizing the protocol. This is particularly important for PMA and De Novo pathways, but also valuable for 510(k) submissions where clinical data is a significant component. bioaccess® has experience preparing and supporting Q-Sub interactions with FDA.

Protocol Design Principles

When designing a LATAM trial protocol intended for FDA submission, the following principles should guide every decision:

• Endpoints — Select primary endpoints that align with FDA's expectations for the intended submission pathway. For 510(k), this typically means demonstrating substantial equivalence. For PMA, endpoints must demonstrate reasonable assurance of safety and effectiveness.
• Control Strategy — Define the comparator or control group in alignment with FDA expectations. Active controls, sham controls, or historical controls each have different evidentiary weight at FDA.
• Sample Size — Power the study to detect clinically meaningful differences with adequate statistical rigor. Even for early feasibility studies, a pre-specified statistical analysis plan strengthens the submission.
• Population Considerations — Define inclusion/exclusion criteria that produce a study population relevant to the intended U.S. patient population. Overly restrictive criteria may limit generalizability; overly broad criteria may introduce confounders.

Site Selection for FDA Credibility

Not all clinical sites are equally credible in FDA's assessment. When selecting LATAM sites for an FDA-directed study, consider:

• Standard of Care Alignment — The treating institution should provide a standard of care comparable to what patients receive in the United States. This includes access to imaging, laboratory testing, post-operative care, and follow-up capabilities.
• Site Volume — Sites should have adequate patient volume to meet enrollment timelines without compromising inclusion/exclusion criteria.
• Infrastructure — Research-grade infrastructure including secure data management, temperature-controlled storage for devices, calibrated equipment, and trained research coordinators.
• Patient Demographics — Site patient populations should be reasonably comparable to the intended U.S. population in terms of disease severity, comorbidities, and treatment history.
• Language Capabilities — While not strictly required, having English-proficient clinical staff facilitates communication during FDA inspections and sponsor monitoring visits.

Documentation and Quality Systems

Documentation quality can make or break an FDA submission based on foreign clinical data. The essential documentation package includes:

• Clinical Study Report (CSR) — Written in English, following ICH E3 guidelines, with complete statistical tables, figures, and listings.
• Protocol and all amendments — With rationale for each amendment and assessment of impact on data integrity.
• Investigator Brochure — Current version reflecting all available preclinical and clinical data at the time of the study.
• IEC approval letters — For each participating site, with certified English translations.
• Informed consent forms — Blank forms and documentation of the consent process.
• Monitoring reports — Complete monitoring visit reports demonstrating adequate oversight.
• Source data verification (SDV) summary — describe the SDV scope applied to primary endpoint data.
• Device accountability records — Complete chain of custody for every device unit used in the study.

**📋 Monitoring intensity: full SDV for primary endpoints**

For LATAM studies intended for FDA PMA or De Novo submissions, bioaccess® recommends full source data verification (SDV) of primary endpoint data and risk-based SDV of secondary endpoint data. This exceeds the minimum ISO 14155 requirement but significantly strengthens the data's credibility with FDA reviewers and demonstrates the sponsor's commitment to data integrity.

What Is the 21 CFR 812.28(a) Compliance Checklist?

The following checklist maps each requirement of 21 CFR 812.28(a) to the specific documentation sponsors should prepare for their FDA submission. This checklist should be used as a planning tool during study design and as an audit tool during study conduct.

The GCP compliance narrative is a critical document that many sponsors overlook. This narrative should be structured as follows:

• Overview — Brief description of the clinical investigation, sites, and countries involved.
• Point-by-Point Demonstration — Address each element of 21 CFR 812.28(a) with specific references to study documentation.
• Device Comparability — Detailed comparison between the device used in the LATAM trial and the device that is the subject of the U.S. marketing application.
• Valid Scientific Evidence — Explanation of how the study design, conduct, and results meet the 21 CFR 860.7 definition of valid scientific evidence.
• Investigator Qualifications — Summary of each investigator's relevant qualifications and experience.

How Do You Address FDA's Core Concerns About Foreign Data?

FDA reviewers consistently focus on three main areas when evaluating foreign clinical data for device submissions. Understanding these concerns — and proactively addressing them in your submission — is essential for a smooth review process.

Concern 1: Applicability to the U.S. Population

FDA's question: "Are the results from this foreign study population applicable to the intended U.S. patient population?"

This is typically the most significant concern FDA raises about foreign data. To address it proactively:

• Demographic Comparison — Provide a baseline demographics table comparing your LATAM study population to the U.S. target population using NHANES, CDC, or disease-specific registry data (e.g., STS database for cardiac, NSQIP for surgical outcomes).
• Subgroup Analyses — Pre-specify subgroup analyses by age, sex, BMI, disease severity, and relevant comorbidities. These demonstrate that treatment effects are consistent across demographic subgroups.
• Literature Comparison — Reference published literature comparing disease presentation and treatment outcomes between LATAM and U.S. populations for the relevant indication.

**Example Positioning Statement**

"The study population enrolled at [Site Name] in [Country] is comparable to the intended U.S. population in terms of age distribution [study mean ± SD vs. U.S. reference], BMI [values], disease severity [classification], and relevant comorbidities [rates vs. U.S. reference]. Subgroup analyses demonstrate consistent treatment effects across all demographic subgroups analyzed."

Concern 2: Applicability to U.S. Medical Practice

FDA's question: "Was the standard of care at the foreign site comparable to U.S. practice, and are the clinical results transferable?"

• Standard of Care Documentation — Describe the treating institution's capabilities, including imaging equipment, laboratory certifications, ICU/recovery capabilities, and follow-up infrastructure.
• Site Comparability — Document how the clinical practice at the LATAM site mirrors U.S. standard of care for the relevant procedure or indication.
• Operator Experience — Provide detailed documentation of the principal investigators' training, case volumes, and proficiency with the procedure or device.

"[Hospital Name] is a [accreditation] accredited institution with [X] beds, [Y] annual procedures in the relevant specialty, and full diagnostic imaging capabilities including CT, MRI, and fluoroscopy. The principal investigator, Dr. [Name], has performed [Z] procedures in the relevant anatomical area and has [W] years of experience in clinical research, including [N] prior device investigations."

Concern 3: Data Integrity and GCP Compliance

FDA's question: "Can we trust the quality and integrity of the data generated at these foreign sites?"

• Monitoring Intensity — Document the monitoring plan, including SDV scope, visit frequency, and escalation procedures. For pivotal studies, full SDV of primary endpoint data is strongly recommended.
• Central Review and Adjudication — Implement an independent Clinical Events Committee (CEC) for endpoint adjudication and a core laboratory for imaging assessment, where applicable.
• Audit Results — Conduct internal quality audits during the study and include summary findings in the submission.
• Inspection Readiness — Maintain all source documents in an inspection-ready state throughout the study. Ensure documents are organized, complete, and accessible at the site.

"The sponsor implemented a comprehensive quality management plan including: full SDV of primary and key secondary endpoint data, regular monitoring visits, centralized statistical monitoring for data anomaly detection, an independent Clinical Events Committee for endpoint adjudication, and a pre-planned internal quality audit at each site. No critical findings were identified during sponsor audits."

How Can Latin American Data Support Each FDA Regulatory Pathway?

Latin American clinical data can be used strategically across every FDA regulatory pathway for medical devices. The appropriate strategy depends on the pathway, the classification of the device, and the type and volume of clinical evidence required.

510(k): Supporting Substantial Equivalence

For 510(k) submissions, LATAM clinical data can serve as supplementary evidence supporting substantial equivalence when clinical data is needed to demonstrate equivalent safety and/or effectiveness. This is most relevant for:

• 510(k) submissions where the predicate device has different technological characteristics and clinical data is needed to address performance concerns.
• 510(k) with clinical data requested by FDA during a pre-submission interaction.
• De novo-like 510(k) submissions where there is limited clinical experience with the device type.

**Typical 510(k) Data Package**

A LATAM clinical study with a sample size and follow-up period justified in the protocol (and ideally agreed with FDA in a Pre-Submission), demonstrating safety endpoints comparable to the predicate device and no unexpected adverse events.

De Novo: LATAM Data as Pivotal Evidence

De Novo classification requests are one of the strongest use cases for LATAM clinical data. Since De Novo devices are novel (no predicate), clinical data is almost always required, and LATAM data can serve as the primary or sole clinical evidence.

• LATAM data demonstrating the device meets proposed special controls for the new device type.
• Sufficient follow-up data to characterize the risk profile and establish performance criteria.
• Clear documentation of how the data supports the proposed device classification and special controls.

**Typical De Novo Data Package**

A statistically justified sample size and follow-up period, well-defined primary and secondary endpoints, and a comprehensive safety profile including all adverse events. A GCP compliance narrative and ISO 14155 conformance statement are essential.

Premarket Approval (PMA)

PMA is the most rigorous pathway, requiring "reasonable assurance of safety and effectiveness." LATAM data can be used in several ways:

• LATAM-Only PMA — Feasible but rare. Requires compelling, large-scale LATAM data with robust GCP documentation.
• Global Pivotal with LATAM Sites — The most common approach. LATAM sites contribute patients to a global pivotal study that includes U.S. and non-U.S. sites.
• LATAM First-in-Human + U.S. Pivotal — LATAM early feasibility data supports an FDA IDE application for a U.S. pivotal study. This is the ReGelTec HYDRAFIL model.
• LATAM Data Supporting U.S. PAS (Post-Approval Study) — LATAM data complements U.S. pivotal data as part of the post-approval surveillance strategy.

**Typical PMA Data Package**

A statistically powered sample size and follow-up period agreed with FDA, randomized controlled study design (preferred), independent endpoint adjudication, and comprehensive GCP compliance narrative. FDA inspection of LATAM sites is likely for PMA applications.

IDE: OUS Data Supporting U.S. Clinical Trials

One of the most strategically powerful uses of LATAM data is supporting an IDE application for a U.S. clinical trial. LATAM early feasibility or pilot data demonstrates:

• Device safety profile — Characterizing the types and rates of adverse events to inform the U.S. study's safety monitoring plan.
• Procedural feasibility — Demonstrating the device can be safely and effectively deployed in the clinical setting.
• Preliminary effectiveness signals — Providing early evidence of clinical benefit to support the scientific rationale for the U.S. study.
• Protocol refinement — Informing inclusion/exclusion criteria, endpoint selection, and follow-up schedules for the U.S. pivotal trial.

Breakthrough Device Designation

The FDA's Breakthrough Device Designation program provides prioritized review, interactive communication, and greater flexibility in clinical study design. LATAM data can support a Breakthrough Device request in several ways:

• Preliminary LATAM data from a small early study can help demonstrate that the device provides a clinically meaningful advantage over existing alternatives.
• LATAM pilot data can establish the safety profile and preliminary effectiveness needed for the Breakthrough Device application.
• Once Breakthrough Device Designation is granted, FDA may accept a less burdensome clinical evidence package, potentially allowing LATAM data to play an even larger role in the marketing submission.

Does the FDA Inspect Latin American Trial Sites?

Under 21 U.S.C. § 374, FDA has the authority to inspect any clinical trial site — domestic or foreign — where data was generated to support an FDA marketing application. For LATAM trials, sponsors should anticipate potential FDA inspections, particularly for:

• Pre-approval inspections — Conducted before FDA makes a decision on a PMA or high-risk De Novo application.
• For-cause inspections — Triggered by data anomalies, safety signals, or reviewer concerns identified during application review.
• Surveillance inspections — Routine inspections of clinical investigators, selected based on FDA's risk-based inspection planning.

**What FDA announced in May 2025**

On May 6, 2025 FDA announced expanded use of unannounced inspections at foreign manufacturing facilities (FDA press announcement). The announcement is about manufacturing sites, not clinical trial sites. For clinical data, 21 CFR 812.28(a)(3) requires that FDA be able to validate the data through an onsite inspection or other appropriate means (21 CFR 812.28), so sites should keep inspection-ready files throughout the study.

Preparing LATAM Sites for FDA Inspection

bioaccess® prepares all clinical trial sites for potential FDA inspection from Day 1 of study activation. Our inspection readiness program includes:

• Logistics Preparation — Ensuring the site has adequate space for FDA inspectors to work, including a dedicated inspection room with access to all study files, internet connectivity, and photocopying capabilities.
• Documentation Review — Pre-inspection audit of all source documents, regulatory files, IEC correspondence, consent forms, device accountability logs, and monitoring reports. Documents are organized in a structured filing system aligned with FDA inspection protocols.
• Mock Inspection — Conducting a simulated FDA inspection with the site team, including mock interviews with investigators and coordinators, to identify and remediate any gaps before the actual inspection.
• During-Inspection Protocol — Defined procedures for responding to inspector requests, providing documents, facilitating interviews, and documenting all inspection activities in real-time.
• Post-Inspection Follow-up — Managing the response to any FDA Form 483 observations, including drafting corrective action plans and tracking implementation to completion.

Common FDA Inspection Findings at Foreign Sites

Findings that inspections of clinical sites commonly focus on include:

• Consent Documentation — Missing or incomplete consent forms, consent obtained after procedures, consent not re-obtained after protocol amendments, or lack of documentation of the consent discussion.
• Source Documentation Gaps — Missing source data for key clinical assessments, inconsistencies between source and CRF data, or retrospective documentation of clinical events.
• Protocol Deviations — Undocumented protocol deviations, deviations not reported to IEC, or failure to implement corrective actions for recurring deviations.
• Device Accountability — Incomplete chain of custody records, missing serial numbers or lot numbers, or gaps in device return/disposition documentation.
• AE/SAE Reporting Delays — Failure to report adverse events within required timelines, incomplete AE/SAE narratives, or lack of documented causality assessments.

FDA inspection record in Latin America

FDA's own public inspection records show it already relies on Latin American clinical data. FDA's Data Dashboard lists 247 FDA inspections of clinical investigators and research firms in 13 Latin American countries between October 2008 and August 2026, including 22 in Chile, 13 in Colombia and 3 in Panama. None of the 248 resulting classifications was Official Action Indicated (OAI), compared with about 2.6% of clinical-investigator results worldwide in the same dataset.

These are FDA's region-wide figures, not results for bioaccess® sites. Most are drug-trial inspections (only 3 device inspections region-wide), and FDA selects whom to inspect. NAI = No Action Indicated; VAI = Voluntary Action Indicated. One inspection can carry two classifications, which is why 247 inspections produced 248 classifications.

Source: Bioresearch Monitoring inspections, accessed October 16, 2026 (FDA Data Dashboard).

What Drives the Cost of a LATAM Trial for an FDA Submission?

Budget depends on study design, and every study is priced in a written, study-specific proposal. See our guide to clinical trial cost drivers in Latin America.

Main Cost Drivers

• Protocol complexity: number of visits, procedures, imaging and follow-up length
• Number of sites and subjects, and how hard the target population is to enroll
• Country choice: regulator and ethics-committee fees and requirements differ by country
• Device logistics: import permits, customs, storage and in-country inventory
• Monitoring intensity and source data verification scope
• Insurance, translations and data-management requirements for an FDA-ready dataset

Timeline Considerations

Timelines depend on the country, the ethics committee, the regulator's review queue and how complete the submission is. Running ethics and regulatory review in parallel where the country allows it, and preparing a complete dossier up front, are the main levers a sponsor controls. Earlier clinical data can matter to early-stage companies working toward fundraising, partnership or acquisition milestones.

Risk Considerations and Mitigation

What Are the Best Practices for Executing a LATAM FIH Study?

Strategic Decision Framework: When to Choose LATAM

LATAM clinical trials are not the right choice for every device or every regulatory strategy. The following framework helps sponsors make informed decisions:

✅ Strongly Recommended

• First-in-human or early feasibility studies for any device class
• Pilot studies to generate preliminary safety and efficacy data for IDE applications
• De Novo submissions where clinical data is the primary evidence
• Startups and emerging companies with limited capital seeking to maximize clinical data per dollar
• Companies seeking Breakthrough Device Designation based on preliminary clinical data

⚠️ Requires Careful Evaluation

• PMA applications based solely on foreign data — feasible but requires exceptional data quality and proactive FDA engagement
• Devices where the U.S. standard of care differs significantly from LATAM practice
• Indications where disease presentation or prevalence varies substantially between populations

❌ U.S.-Only Preferred

• FDA has explicitly communicated that U.S. data is required (rare, but occurs in specific Pre-Sub feedback)
• Devices requiring integration with U.S.-specific healthcare infrastructure (EHR systems, insurance billing codes)
• Post-market studies mandated by FDA as conditions of approval (unless FDA specifically approves OUS sites)

Three-Phase Execution Framework

Phase 1: Planning (before first patient)

• File Q-Sub with FDA to align on protocol design, endpoints, and acceptability of LATAM data
• Select target country/countries and initiate regulatory intelligence gathering
• Finalize protocol design incorporating FDA feedback, ISO 14155 requirements, and local regulatory requirements
• Complete site feasibility assessment and select clinical sites
• Prepare Investigator Brochure with complete preclinical data package
• Develop clinical monitoring plan with full SDV specification for primary endpoints
• Establish device supply chain, customs clearance pathway, and in-country inventory

Phase 2: Execution

• Submit to IEC and national regulatory authority
• Activate sites and begin enrollment
• Conduct regular monitoring visits per monitoring plan
• Implement centralized statistical monitoring for data quality surveillance
• Manage safety reporting per ISO 14155 and local requirements
• Conduct pre-planned internal quality audits at each site
• Prepare interim reports for sponsor review and potential FDA communication

Phase 3: Submission Preparation

• Database lock and statistical analysis
• Draft Clinical Study Report per ICH E3 guidelines
• Prepare GCP compliance narrative addressing each 21 CFR 812.28(a) requirement
• Compile device comparability documentation
• Prepare demographic comparison and population representativeness analysis
• Assemble complete regulatory submission package
• Conduct final inspection readiness assessment at all sites

CRO Partner Selection Criteria

Selecting the right CRO partner is critical for a successful LATAM-to-FDA strategy. The following criteria should guide your evaluation:

Frequently Asked Questions

References

21 CFR § 812.28 — Acceptance of Data from Clinical Investigations Conducted Outside the United States. U.S. Code of Federal Regulations.

21 CFR § 860.7 — Determination of Safety and Effectiveness. U.S. Code of Federal Regulations.

21 CFR § 312.120 — Foreign Clinical Studies Not Conducted Under an IND. U.S. Code of Federal Regulations.

21 CFR § 814.15 — Research Conducted Outside the United States (PMA). U.S. Code of Federal Regulations.

FDA Guidance: "Acceptance of Clinical Data to Support Medical Device Applications and Submissions" (2018). U.S. Food and Drug Administration.

FDA Guidance: "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." U.S. Food and Drug Administration.

ISO 14155:2020 — Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice. International Organization for Standardization.

FDA Guidance: "FDA's Use of ISO 14155: Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice in the Premarket Review" (2023). U.S. Food and Drug Administration.

ICH E6(R3) — Guideline for Good Clinical Practice (Step 4, 6 January 2025). International Council for Harmonisation.

21 U.S.C. § 374 — Inspections. United States Code, Title 21, Chapter 9.

Section 1123, FDA Safety and Innovation Act (FDASIA) — Standards for Clinical Investigations. Public Law 112-144 (2012).

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