From Latin America to FDA: Your Complete Guide to First-in-Human Studies, Regulatory Requirements & Pre-Study Testing

Three questions every MedTech sponsor asks before launching a First-in-Human study in Latin America — and the detailed answers backed by regulatory precedent and real-world case studies.

February 21, 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

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:

• 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.

Case Studies: Latin American Data Supporting FDA Submissions

ReGelTec is developing HYDRAFIL, a percutaneous hydrogel implant for chronic low back pain caused by degenerative disc disease. ReGelTec chose Colombia and bioaccess® to conduct the first-in-human clinical trial of the HYDRAFIL System.

That Early Feasibility Study enrolled 11 patients at Centro Médico Cediul in Barranquilla, Colombia. The Colombian clinical data became the foundation for ReGelTec's entire regulatory strategy. They expanded from those initial 11 patients to 75 patients treated outside the United States.

That OUS data secured CE Mark under the EU MDR for the Class III HYDRAFIL System, with results showing greater than 80% improvement in ODI scores and greater than 70% reduction in pain scores sustained over 2 years.

The same OUS data package supported FDA approval of an Investigational Device Exemption (IDE) for the HYDRAFIL-D pivotal study — a 225-patient, multicenter, randomized controlled trial now actively enrolling across nine U.S. sites. In January 2026, ReGelTec published 1-year results in Pain Physician journal.

bioaccess® supported enVVeno's early first-in-human clinical work in Latin America. On April 29, 2026, enVVeno's next-generation, non-surgical enVVe® System received the first-ever FDA IDE approval for a U.S. pivotal study — the TAVVE® study — in severe deep chronic venous insufficiency. The IDE authorizes the U.S. pivotal STUDY; it is not a device clearance or approval. All enVVeno devices remain investigational.

Axoft completed the first four cases of its first-in-human brain-computer interface study (FINESSE) at The Panama Clinic, with patients implanted during brain-tumor resection. 11 patients have now been implanted worldwide. In April 2026, Axoft closed a $55M Series A (led by C.P. Group Innovation; >$60M total raised) and holds FDA Breakthrough Device Designation (2022). The data supports Axoft's continued FDA engagement.

Newrotex received a 15-day ethical approval in Panama for its first-in-human silk nerve guide study. The company has filed a Pre-Submission Meeting Request with the FDA for a 510(k) pathway using the Latin American data.

**50+ First-in-Human Studies in Latin America**

More than 50 first-in-human studies have been conducted in Latin America for products that went on to receive CE marks, FDA approvals, or were acquired by large strategic buyers.

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

Latin American countries offer streamlined, sponsor-friendly regulatory pathways compared to the United States and the European Union. Each country has its own national regulatory authority and Independent Ethics Committees, but the general framework is consistent across the region — and significantly faster than traditional markets.

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.

**No Separate IND or IDE Required**

Most Latin American countries do not require a separate Investigational New Drug (IND) or Investigational Device Exemption (IDE) equivalent. The regulatory submission goes directly to the Ethics Committee and the national regulatory authority.

Typical approval timeline: 4–8 weeks from submission to study authorization, depending on the country.

**🌎 bioaccess® Regional Presence**

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

Key Submission Requirements

• Study Protocol (ICH-GCP 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 ICH-GCP (E6 R2)

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 (minimum 6-month data)

3.5 Animal and Preclinical Efficacy Studies

• Small animal models (rodent) for proof-of-concept
• Large animal models (porcine or ovine spine 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

• GMP Certificate or summary letter demonstrating GMP-compliant manufacturing
• ISO 13485 certification for the quality management system

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.

Real-World Precedent: The ReGelTec HYDRAFIL Preclinical Testing Package

Latin American regulatory authorities such as INVIMA (Colombia) do not prescribe a specific list of preclinical tests — the burden of proof rests on the sponsor to demonstrate the device is safe for first-in-human use. This approach is consistent across the region. The following is the actual preclinical testing package submitted by ReGelTec for the HYDRAFIL System — reviewed and accepted by INVIMA and the Independent Ethics Committee.

Biocompatibility Testing (ISO 10993 Series)

Genotoxicity Testing

Chemical Characterization & Risk Assessment

**All 12 Preclinical Studies — GLP Compliant**

All 12 preclinical studies were conducted under Good Laboratory Practice (GLP) where applicable, and compiled into a Biocompatibility Summary Report that was reviewed and accepted by both INVIMA and the Independent Ethics Committee.

FDA Regulatory Framework for Foreign Device Clinical 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 Section 812.28(a), FDA will accept data from a clinical investigation conducted outside the United States to support a device marketing application if the following criteria are satisfied:

• GCP Compliance — The investigation was conducted in accordance with Good Clinical Practice (GCP), including review and approval by an independent ethics committee (IEC) and informed consent of subjects.
• IEC Review and Approval — An Independent Ethics Committee that meets the requirements of the applicable GCP standard reviewed and approved the investigation.
• Informed Consent — Subjects gave informed consent consistent with GCP requirements and applicable local law.
• Monitoring — The sponsor monitored the investigation adequately to ensure quality and integrity of data.
• Accurate Records — Accurate, complete records of the investigation were maintained.
• Device Identity and Comparability — The device tested is identical to or adequately compared with the device that is the subject of the marketing application (21 CFR 812.28(a)(2)).
• Valid Scientific Evidence — The data constitute valid scientific evidence as defined in 21 CFR 860.7, meaning the evidence is generated by adequate and well-controlled investigations, partially controlled studies, studies without matched controls, well-documented case histories, or reports of significant human experience.
• Qualified Investigators — The clinical investigators were qualified by training and experience to conduct the investigation.

The Flexibility Provision: 21 CFR 812.28(e)

A critically important — and often overlooked — provision exists in 21 CFR 812.28(e). This subsection states that FDA may accept foreign clinical data even if not all conditions of 812.28(a) are met, provided:

• The data are otherwise credible and scientifically sound.
• The rights, safety, and well-being of subjects were adequately protected.
• FDA determines the data are adequate for the intended regulatory purpose.

**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 (R2) — The international harmonized standard for GCP in clinical trials, covering investigator responsibilities, sponsor obligations, IEC review, and 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.

ISO 14155:2020 Implementation for 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.

FDA has published specific guidance on its use of ISO 14155 in premarket reviews and has stated that conformance with ISO 14155:2020 will generally satisfy the GCP requirement of 21 CFR 812.28. This makes ISO 14155 the de facto bridge between Latin American regulatory requirements and FDA expectations.

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. ANVISA timelines are typically 90–120 days for clinical investigation authorization.

Mexico (COFEPRIS)

COFEPRIS requires a clinical trial authorization with 60–90 day review timelines. Mexico offers a large, diverse patient population with significant clinical research infrastructure. Ethics committee review runs in parallel with COFEPRIS authorization, reducing overall timelines.

Colombia (INVIMA)

INVIMA is recognized as a Level 4 health authority by the Pan American Health Organization. Colombia offers some of the fastest regulatory timelines in the region — 4–6 weeks from submission to authorization — with a well-established clinical research ecosystem and experienced investigators. bioaccess®® has its headquarters in Colombia and deep relationships with INVIMA.

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.

Building 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 within 75 calendar days.
• 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 — FDA expects 100% SDV of primary endpoint data for pivotal studies.
• Device accountability records — Complete chain of custody for every device unit used in the study.

**📋 Monitoring Intensity: 100% SDV for Primary Endpoints**

For LATAM studies intended for FDA PMA or De Novo submissions, bioaccess® recommends 100% source data verification (SDV) of primary endpoint data and at minimum 20% 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.

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.

Addressing FDA's Core Concerns About Foreign Clinical 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 (mean 58 ± 12 years vs. 56 ± 14 years in NHANES), BMI (28.3 ± 4.1 vs. 29.1 ± 5.8), disease severity (NYHA Class II–III), and relevant comorbidities (diabetes 32% vs. 34%, hypertension 61% vs. 58%). 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 percentages, visit frequency, and escalation procedures. For pivotal studies, 100% 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: 100% SDV of primary and key secondary endpoint data, monthly 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."

Strategic Use of Latin American Data Across FDA Regulatory Pathways

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 20–50 subjects and 6–12 months of follow-up data, 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**

50–100+ subjects with 12+ months of follow-up data, 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**

150–300+ subjects with 24+ months of follow-up, 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 as few as 10–20 subjects can 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.

**Axoft Example**

Axoft's FINESSE brain-computer interface study in Panama — with initial data from just 4 patients — is being used to support the company's FDA engagement strategy, including potential Breakthrough Device Designation. This demonstrates that even very early LATAM data can have strategic value in the FDA pathway.

FDA Inspection of 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.

**⚠️ 2025 Update: Expanded Unannounced Inspections**

As of 2025, FDA has expanded its use of unannounced inspections at foreign clinical trial sites. Unlike pre-announced inspections (which typically provide 2–4 weeks notice), unannounced inspections arrive with minimal or no advance warning. This underscores the importance of maintaining inspection-ready documentation at all times 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

Based on publicly available FDA inspection data and bioaccess®'s experience preparing sites for regulatory inspections, the most common findings at foreign clinical trial sites 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.

**bioaccess® Inspection Track Record**

bioaccess® has managed 50+ clinical investigations across Latin America. Our comprehensive quality management system and inspection readiness program are designed to ensure that every site meets or exceeds the standards FDA inspectors expect. We build inspection readiness into the study from Day 1 — not as an afterthought.

Cost-Benefit Analysis: LATAM Trials for FDA Submissions

One of the most compelling reasons to conduct clinical trials in Latin America for FDA submissions is the significant cost and timeline advantages compared to conducting the same studies in the United States. These savings can be transformative for emerging MedTech companies with limited capital.

Cost Comparison: LATAM vs. U.S. Clinical Trials

**💰 Total Program Savings Example**

A 200-subject pivotal study costs approximately $5–10 million in the United States. The same study conducted in Latin America with equivalent quality and FDA-submissible documentation costs approximately $1.6–3.0 million — a savings of $3.4–7.0 million, or 60–75% overall cost reduction.

Timeline Advantages

The 6–12 month timeline advantage is particularly valuable for early-stage companies seeking to reach clinical data milestones for fundraising, partnership negotiations, or strategic acquisition discussions.

Risk Considerations and Mitigation

Practical Recommendations and Execution Best Practices

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 (6–9 Months 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 100% SDV specification for primary endpoints
• Establish device supply chain, customs clearance pathway, and in-country inventory

Phase 2: Execution (18–24 Months)

• 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 (3–6 Months)

• 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

1

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

2

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

3

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

4

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

5

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

6

FDA Guidance: "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" (2021). U.S. Food and Drug Administration.

7

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

8

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.

9

ICH E6 (R2) — Guideline for Good Clinical Practice. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

10

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

11

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

Ready to Launch Your First-in-Human Study in Latin America?

Whether you're a MedTech startup planning your first clinical milestone or an established Biopharma company exploring radiopharmaceutical trials, bioaccess® provides the regulatory strategy, clinical operations, and regional expertise to move from preclinical data to patient enrollment — faster, with lower cost, and with FDA-submissible data. a MedTech startup planning your first clinical milestone or an established Biopharma company exploring radiopharmaceutical trials, bioaccess® provides the regulatory strategy, clinical operations, and regional expertise to move from preclinical data to patient enrollment — faster, with lower cost, and with FDA-submissible data., clinical operations, and regional expertise to move from preclinical data to patient enrollment — faster, with lower cost, and with FDA-submissible data.

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