Will the FDA Accept Clinical Data from Latin America? Your Complete Guide to 21 CFR 812.28 and 312.120

The #1 objection sponsors raise before launching a clinical trial in Latin America — and the regulatory framework that answers it definitively.

March 25, 2026

18

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

FDA

21 CFR 812.28

21 CFR 312.120

Latin America

Clinical Data

Regulatory

GCP

The #1 Sponsor Objection — Answered

"Will the FDA accept my clinical data from Latin America?" This is the single most common question MedTech, Biopharma, and Radiopharma sponsors ask when considering a first-in-human trial outside the United States. The concern is understandable — your entire regulatory strategy depends on the answer.

The answer is unequivocally yes. The FDA has established clear, codified regulatory pathways for accepting foreign clinical data. These are not workarounds or exceptions — they are the FDA's intended framework for evaluating clinical evidence generated anywhere in the world. Since 2010, bioaccess® has helped 50 companies successfully use Latin American clinical data for FDA submissions, including IDE applications, 510(k) clearances, De Novo classifications, and PMA supplements.

**Key Regulatory References**

21 CFR 812.28 — Acceptance of foreign clinical data for medical devices21 CFR 312.120 — Acceptance of foreign clinical data for drugs and biologics21 CFR 814.15 — Foreign data in PMA applicationsFDASIA Section 1123 — FDA strategies for utilizing foreign clinical data

21 CFR 812.28: Medical Devices

For medical device sponsors, 21 CFR 812.28 is the governing regulation. It states that the FDA will accept foreign clinical data to support an IDE, 510(k), De Novo, PMA, or HDE submission when three conditions are met:

• The investigation was conducted in accordance with Good Clinical Practice (GCP), including review and approval by an Independent Ethics Committee (IEC).
• The study data are valid and can be verified by FDA inspection if necessary.
• The device tested is identical to — or adequately compared with — the device submitted for US marketing authorization.

Critically, Section 812.28(e) provides additional flexibility: even when a foreign study does not fully meet all conditions, the FDA may still accept the data if it determines the evidence is credible, the investigation was scientifically valid, and patient rights were adequately protected.

This flexibility provision is significant for LATAM studies where minor procedural differences from US practices exist (e.g., informed consent language, ethics committee structure) but do not compromise data integrity or patient safety.

21 CFR 312.120: Drugs & Biologics

For drug and biologic sponsors, 21 CFR 312.120 establishes the parallel framework for accepting foreign clinical studies not conducted under an IND. The FDA will accept foreign clinical data when:

• The study was conducted in accordance with GCP, including review and approval by an independent ethics committee that meets ICH E6 requirements.
• The FDA is able to validate the data through site inspection if needed.
• The study data are applicable to the US population and US medical practice.

Section 312.120(b) adds an important provision for drugs: the FDA may accept foreign data even from studies not conducted under GCP if the data are scientifically credible and necessary to support the application. This is a broader flexibility than what 812.28 provides for devices.

What the FDA Actually Evaluates

Beyond the regulatory citations, understanding what the FDA actually looks at when reviewing foreign clinical data is essential for designing a submission-ready study. Here are the five key evaluation areas:

Investigator Qualifications

The FDA evaluates whether the principal investigator and sub-investigators have appropriate medical training, clinical experience in the relevant therapeutic area, and GCP certification. bioaccess® pre-qualifies all investigators in its 50+ site network, verifying board certifications, publication history, prior clinical trial experience, and GCP training documentation.

Facility Descriptions

Clinical sites must have appropriate infrastructure for the study: operating rooms, imaging equipment, laboratory services, emergency capabilities, and monitoring space. bioaccess® conducts site qualification visits and documents facility capabilities as part of every study's regulatory dossier.

GCP Compliance

This is the cornerstone of FDA acceptance. The FDA evaluates whether the study was conducted in compliance with ICH E6(R2) Good Clinical Practice guidelines, including proper informed consent procedures, adverse event reporting, data integrity controls, and source data verification. bioaccess® maintains ACRP-certified Clinical Research Associates who conduct on-site monitoring to GCP standards.

Ethics Committee Information

The FDA requires documentation that the study was reviewed and approved by an Independent Ethics Committee (IEC) that meets ICH E6 requirements. This includes the committee's composition, review procedures, approval documentation, and ongoing safety review records. Latin American ethics committees — particularly INVIMA-accredited committees in Colombia — maintain documentation standards comparable to US IRBs.

Informed Consent

Informed consent documents must meet the substantive requirements of 21 CFR 50 (for devices) or 21 CFR 50 and ICH E6 (for drugs). Consent forms must be in the local language and translated into English for FDA review. bioaccess® develops bilingual informed consent templates that satisfy both local regulatory requirements and FDA standards.

Why Latin America Meets FDA Criteria

Latin America's clinical research infrastructure has matured significantly over the past two decades. The region's major regulatory agencies are aligned with international standards:

• INVIMA (Colombia) — Level 4 WHO regulatory authority, ICH-GCP certified hospitals, ethics approval in 4-6 weeks
• ANVISA (Brazil) — Largest LATAM regulatory agency, CONEP oversight for novel technologies, comprehensive GCP inspection program
• COFEPRIS (Mexico) — Trusted Regulatory Practices (Reliance) framework recognizing FDA/EMA approvals, 30-day abbreviated pathway
• ANMAT (Argentina) — ICH member, rigorous GCP oversight, strong medical device regulatory framework
• DNM (El Salvador) — 30-day parallel review, 98.5% GCP compliance rate across bioaccess® sites

These agencies maintain inspection programs, require GCP training for investigators, and enforce adverse event reporting standards that mirror FDA requirements. When bioaccess® manages a study, sites are prepared for potential FDA inspection from Day 1.

Common Documentation Mistakes That Jeopardize FDA Acceptance

Based on 15+ years of experience supporting FDA submissions with LATAM data, here are the documentation errors bioaccess® most commonly sees — and prevents:

• Missing or incomplete device comparison documentation (21 CFR 812.28(a)(2)) — the US submission device must be clearly compared to the device used in the foreign study
• Informed consent forms that satisfy local requirements but miss FDA-specific elements (e.g., statement about FDA inspection rights)
• Ethics committee approval letters that lack required details (committee composition, quorum, voting record)
• Inadequate source data verification documentation — FDA expects monitor reports demonstrating CRF data matches source documents
• Missing or delayed adverse event reporting — all adverse events must be documented, classified, and reported per GCP timelines regardless of local requirements
• Failure to maintain English-language translations of all key study documents concurrent with the study
• Protocol deviations not properly documented and reported to the ethics committee and sponsor

Timeline and Cost Comparison: LATAM vs. US/EU

The cost savings are substantial, but the timeline advantage is often more valuable. Getting FIH data 6–12 months faster means earlier FDA pre-submission meetings, earlier fundraising milestones, and earlier strategic conversations with potential acquirers.

Frequently Asked Questions

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If you're a MedTech or Biopharma sponsor considering a first-in-human trial, bioaccess® can help you design an FDA-submissible clinical program with U.S. regulatory anchoring and Latin American execution — meaningfully faster and at lower cost than US/EU pathways.

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