On May 8, 2026, 98 MedTech professionals from 17 countries joined our Friday In Focus webinar on running first-in-human (FIH) clinical trials in Latin America. 59% stayed past 46 minutes in a 62-minute session — and they didn’t ask curiosity questions. They asked execution questions: country selection, ethics, FDA acceptability, statistical power, step-by-step playbooks for medical device sponsors who are actively planning their first FIH outside the United States.

If you’re evaluating whether to run your next first-in-human study in Latin America, here are the five questions your peers pushed hardest on — and how to think about each one before you commit to a country, an ethics committee, or an FDA submission strategy.

1. Which country in Latin America is the easiest?

This was the first question out of the gate, asked by Rocío Paublete (Sweden, PMCF & Clinical Investigation Project Manager) and echoed throughout the chat. The honest answer is: it depends on what you’re optimizing for.

“Easy” decomposes into three orthogonal dimensions:

• Patient recruitment speed — how quickly you can enroll the first 5–30 patients for an FIH or early feasibility study. Colombia, Mexico, and Brazil typically lead here because of dense urban hospital networks and high physician engagement with research.
• Ethics committee turnaround — how long the IRB/CEI review cycle takes from submission to approval. Chile and Costa Rica run faster review cycles than Brazil, where amendments through CONEP can stretch.
• Regulatory authority predictability — INVIMA (Colombia), ANVISA (Brazil), COFEPRIS (Mexico), ANMAT (Argentina), DIGEMID (Peru), and ISP (Chile) all have different timelines, fee structures, and documentation expectations.

For most US-headquartered MedTech sponsors running an FIH, the practical sweet spot is Colombia or Costa Rica for first-patient-in speed, with Brazil considered when the indication requires larger patient diversity or when the eventual commercial path runs through Latin America’s largest market.

2. Are those countries easier because of recruitment, or because of ethics committees?

Rocío came back with this follow-up — and it’s the right one to ask. The two drivers behave differently:

• Recruitment speed is largely a function of investigator network density, hospital infrastructure, and patient population. It’s a relatively stable property of the country and the indication.
• Ethics committee speed varies by which committee, not just which country. A Bogotá-based academic medical center’s CEI may turn around in 4–6 weeks; a regional committee might take 12. The same country can deliver dramatically different timelines depending on site selection.

The implication for sponsors: pick countries where both the recruitment and the committee math work, then pick sites where you’ve already mapped CEI cycle times empirically. Don’t optimize one without the other.

3. Will the FDA accept clinical data generated in Latin America?

This question, from Bhavik Gondaliya (Germany, RA), is the one that gates every conversation about whether LatAm FIH data will actually contribute to a US regulatory submission. The short answer: yes, with conditions.

The FDA’s longstanding position on foreign clinical data is codified in 21 CFR 814.15 for PMA submissions and reflected in their 2018 guidance “Acceptance of Clinical Data to Support Medical Device Applications and Submissions.” LatAm data is acceptable if:

• The study was conducted in accordance with Good Clinical Practice (GCP), including independent ethics review and informed consent
• The data are applicable to the US patient population (the FDA looks for population overlap on the relevant clinical and demographic axes)
• The site investigators were qualified, the protocol was scientifically sound, and the data are auditable by FDA inspectors

For most early-stage MedTech sponsors, the practical playbook is to design the LatAm FIH so that its protocol, endpoints, and case report forms look like what an FDA reviewer would expect to see in a US pivotal study. Doing this work upfront makes the eventual bridging to a US IDE or 510(k)/De Novo dramatically smoother.

4. How do you handle the ethics of providing investigational therapy “for free” in lower-resource settings?

Nyerngoor Korda Hewitt (UK, Director of Regulatory Affairs and Quality) raised this — and it’s a question every sponsor should be ready for. The concern is real: when an FIH protocol provides expensive investigational therapy at no cost in a country where standard care is often unaffordable, you can create undue inducement.

The frameworks that govern this are well-established — the Declaration of Helsinki (especially Articles 19–20 on vulnerable populations), the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, and country-specific implementations. Operationally, robust sponsors design their LatAm FIH protocols to address inducement directly:

• Post-trial access — explicit commitments about whether participants will continue to receive the therapy after the trial ends, and under what conditions
• Standard-of-care arms — when ethically and statistically appropriate, designing comparator arms so participants aren’t forced to choose between trial enrollment and accessible care
• Independent ethics review in the host country, with documented review of the inducement question by the local CEI
• Community engagement — particularly for indications where the trial may shape future access in the country

The audience response on this question made clear: it’s a topic experienced sponsors and their RA teams take seriously, and one ethics committees in Colombia, Mexico, Chile, and elsewhere actively probe.

5. Step-by-step: I have a de novo medical device and I want to do FIH in Panama or Bolivia. What does it actually look like?

This question, from Joseph Skraba (University of Texas at Austin, Manager of Medical Device Commercialization), was the most operational of the session. Here’s the compressed playbook for a de novo Class II/III medical device sponsor:

1. Pre-clinical foundation — bench testing, biocompatibility (ISO 10993), sterilization validation, and animal study data sufficient to support first human exposure. This is non-negotiable.
2. FDA pre-submission (Q-Sub) is optional but strongly recommended — even for studies conducted entirely outside the US, a Q-Sub conversation aligns the FDA’s expectations for how the foreign data will support a future US submission. This is “free insurance” for your eventual regulatory path.
3. Export approval — for a non-US-cleared device, you’ll need an FDA Export Certificate (typically a Certificate to Foreign Government, CFG) under Section 801(e) of the FD&C Act. Lead time is usually 4–6 weeks.
4. In-country regulatory approval — country-specific medical device authorization. INVIMA (Colombia) and ANMAT (Argentina) have streamlined pathways for clinical investigation devices; smaller markets like Panama and Bolivia rely on Ministry of Health approvals that vary in predictability. Plan 8–16 weeks.
5. Ethics committee review — single-site or multi-site CEI approval. Allow 4–12 weeks depending on country and committee. Many sponsors run this in parallel with regulatory.
6. Site activation — investigator agreements, indemnification (and clinical trial insurance — required in most LatAm countries), training on the IFU and protocol, IRT/EDC system rollout.
7. First-patient-in — typically 6–9 months from kickoff for a well-prepared sponsor, faster with an experienced in-country CRO.

The realistic end-to-end timeline from contracting to first-patient-in is 6–9 months for sponsors who arrive prepared, longer for sponsors who try to compress pre-clinical or skip the FDA Q-Sub.

Bonus: “Statistical power with 5 patients?”

Stephanie Grassmann (Switzerland, MedTechXperts LLC) lobbed this one in — and the answer is: FIH studies aren’t powered for inferential statistics, and that’s by design.

An FIH/early-feasibility study (typically 5–30 patients) is designed to evaluate safety, device handling, procedural success, and preliminary signals of efficacy. The endpoints are descriptive: rates, intervals, mean changes from baseline. The next study (pilot or pivotal, often 50–300+ patients) is where powered hypothesis testing begins. The two studies serve different scientific purposes and are evaluated by the FDA on different criteria.

For sponsors evaluating whether their LatAm FIH will “count” toward their eventual US submission: it counts if it answers the questions a 5–30 patient study is designed to answer. Don’t try to make it carry weight it wasn’t designed to bear.

Who was in the room

The 98 attendees came from 17 countries across North America, Europe, Latin America, and Asia, with roles ranging from Regulatory Affairs leaders and Quality directors to MedTech founders and CEOs. The session ran from 11:00 AM to 12:02 PM ET on Friday, May 8, 2026, and 20% of listeners stayed for the final two minutes — an engagement signal that tracks with the seriousness of the questions asked.

Next steps for your team

If your team is actively planning a first-in-human study and wrestling with any of the questions above, here’s how to move forward:

• Free 30-minute feasibility screen — share your indication, target patient count, and target FPI date, and we’ll tell you which 2–3 LatAm countries are realistic for your specific case. Book a call →
• Read the case studies — bioaccess® has supported FIH and early-feasibility studies for cardiology, neurology, ophthalmology, and orthopedic device sponsors across Colombia, Mexico, Chile, Costa Rica, and Brazil. See recent case studies →
• Stay current — we publish new analyses of LatAm regulatory shifts (ANVISA’s 2026–2027 international convergence agenda, FDA’s December 2025 RWE guidance and what it means for LatAm data, ophthalmic FIH dynamics in smaller markets) every week. Subscribe via the form below.

Thanks to the 98 MedTech professionals who joined the session, and to the panelists and moderators who made the depth of the discussion possible. The next Friday In Focus session will be announced shortly.

Ophthalmic First-in-Human Studies in Latin America: Why Smaller Markets Often Move Fastest

For ophthalmic medical device founders running their first-in-human (FIH) program — intravitreal injectors, glaucoma microshunts, retinal delivery platforms, intraocular lens innovations — the conventional wisdom says you go to a country with the largest patient pool and the most prestigious eye institutes. In Latin America, that usually points sponsors toward Mexico or Brazil first.

That instinct is right for pivotal studies. For an FIH or early-feasibility study with 5 to 15 patients, however, our operational experience consistently shows a different pattern: smaller markets like El Salvador, Panama, and the Dominican Republic often deliver a faster path to first patient in. Here is why, and how to think about country selection for an ophthalmic FIH program.

The FIH Math Is Different from the Pivotal Math

Pivotal studies select for patient pool depth, statistical power, and reimbursement signal. FIH studies select for something else entirely: speed to first dose, regulatory predictability, and quality of investigator engagement on a small handful of patients.

For a 10-patient ophthalmic FIH study, the binding constraint is rarely “are there enough eligible patients in the country” — almost any LATAM country has thousands of glaucoma, AMD, or refractive candidates. The binding constraints are:

• Time from sponsor decision to first ethics committee submission
• Time from EC approval to first patient screened
• Investigator focus and availability across the dosing window
• Regulatory predictability for a novel device class

On all four, smaller markets often outperform the regional giants for FIH-stage work.

Why Smaller Markets Move Faster on Ophthalmic FIH

Three structural factors explain it.

1. Lighter EC and regulatory queues. An ethics committee at a leading eye hospital in El Salvador or Panama might review three to six device protocols per quarter. The equivalent committee at a top São Paulo or Mexico City institute might be working through 30 to 60. Both are competent and rigorous; one simply has more capacity for a fast-track FIH protocol.

2. Concentrated investigator attention. In smaller markets, a leading ophthalmologist running an FIH study is not splitting attention across 12 simultaneous trials. The principal investigator has direct line of sight on every screening visit, every dosing event, every follow-up — the kind of operational intimacy that materially reduces protocol deviations and data queries on a small-N study.

3. Tighter sponsor-to-site communication. Smaller hospital systems mean fewer layers between sponsor, CRO, principal investigator, and ethics coordinator. A protocol clarification that takes a week to circulate at a large academic center can be resolved in a 30-minute call in a smaller setting.

What This Looks Like in Practice for an Ophthalmic FIH

For an intravitreal device, glaucoma microshunt, or refractive implant FIH program, a well-structured small-market approach typically looks like this:

• Single-country FIH (5–10 patients). Concentrate enrollment at one or two specialized eye centers in a smaller market. Optimize for speed and data quality, not geographic diversity.
• Validated translation and regulatory packets ready before EC submission. Smaller markets are fast on substance but unforgiving on document inconsistency.
• Compressed feasibility-to-FPI window. A 6 to 8 week target from sponsor go-decision to first patient enrolled is achievable when site, EC, and country regulator are aligned from day one.
• Clean handoff to a multi-country pivotal. Once FIH safety data is in hand, the pivotal can move to Mexico, Brazil, Argentina, or a multi-country footprint with the FIH evidence already supporting site selection conversations.

When the Conventional Path Still Wins

Smaller markets are not the right choice for every ophthalmic FIH. Three situations argue for going to Mexico or Brazil first:

• Genetic ophthalmic indications where a specific sub-population is concentrated in one large country.
• Complex imaging endpoints requiring a specific OCT, ultra-widefield imaging, or AI-assisted analysis platform that is only operational at a handful of large academic centers in the region.
• Founder-led key opinion leader strategy where the FIH publication-to-investor narrative depends on a specific principal investigator’s involvement.

For most early-stage ophthalmic device sponsors, however, the speed advantage of smaller markets at the FIH stage translates directly into reduced cash burn during the most capital-fragile window of the company’s life. In an industry where 90% of MedTech startups fail because they run out of capital before generating clinical evidence, that compression matters.

Frequently Asked Questions

How quickly can a well-designed ophthalmic FIH actually start in a smaller LATAM market?
With prepared documents, an experienced site, and a clear regulatory pathway, 6 to 10 weeks from contract signature to first patient screened is realistic. The variability comes from how prepared the sponsor’s regulatory packet is, not from the country’s regulatory speed.

Will FDA accept FIH data from El Salvador, Panama, or the Dominican Republic?
Yes, under 21 CFR 812.28, provided the study is conducted in compliance with ICH-GCP. The FDA does not maintain a country whitelist; it evaluates each study on the quality of its execution, documentation, and ethics oversight.

Should we run the FIH in a smaller market and then move the pivotal to Brazil or Mexico?
This is a common and effective sequencing strategy for ophthalmic device programs. Smaller markets optimize for speed at the FIH stage. Larger markets optimize for enrollment depth, infrastructure, and regulatory signal at the pivotal stage. Designing the FIH protocol with the eventual pivotal in mind — same imaging modalities, same primary endpoint definitions, same data capture standards — makes the transition seamless.

bioaccess® is the world’s only contract research organization built exclusively for first-in-human medical device trials, operating across 10 Latin American countries. Explore the FIH playbook at bioaccessla.com or estimate a study at bioaccessla.com/clinical-trial-calculator.

ANVISA’s 2026–2027 International Convergence Agenda: What MedTech Sponsors Need to Plan For

Brazil’s medical device regulator, ANVISA, is in the middle of the most aggressive period of international regulatory convergence in its history. Between the mid-2024 Brazilian Clinical Research Law (Lei 14.874) becoming fully operative on January 1, 2025, and the agency’s published 2026–2027 priorities, the rules around clinical trial submissions, post-market surveillance, software as a medical device (SaMD), and unique device identification (UDI) are all changing simultaneously.

For MedTech sponsors planning to use Brazilian clinical data in US, EU, or Brazilian regulatory submissions, the next 18 months are a strategic window. Here is what is changing, why it matters, and how to plan for it.

What Is Actually Changing

Three convergence streams are running in parallel.

1. Stronger international cooperation on device review. ANVISA has expanded its participation in international regulatory work-sharing arrangements, including the Medical Device Single Audit Program (MDSAP) and increased reliance agreements with FDA, EMA, and Health Canada-equivalent regulators. The practical effect: a device that has cleared review in a recognized reference jurisdiction can move through Brazilian registration substantially faster than under the old country-by-country framework.

2. New SIUD database and UDI implementation. ANVISA’s Sistema de Informação de Identificação Única de Dispositivos Médicos (SIUD) is being phased in across 2026, requiring UDI assignment, labeling, and database submission for medical devices entering the Brazilian market. The phase-in follows risk class — Class IV (highest risk) and IVDs first, then descending through Class III, II, and I over the multi-year timeline.

3. Software-as-a-medical-device pathway clarification. ANVISA has published updated normative instructions for SaMD classification, including AI-enabled clinical decision support, aligning more closely with FDA and IMDRF frameworks. For digital health and AI MedTech sponsors, the Brazilian pathway is now substantially more predictable than it was 24 months ago.

All three streams are happening on top of the already-operative parallel review framework under Lei 14.874, which lets sponsors submit to ANVISA and the institutional ethics review system simultaneously rather than sequentially.

Why the Window Matters Now

For sponsors planning a Brazilian arm of a clinical trial — or a market access registration — three strategic implications flow from the current convergence wave.

Documentation prepared for FDA or EU MDR is increasingly leverageable in Brazil. The technical file structure, risk classification reasoning, and clinical evidence summary you build for an FDA 510(k), De Novo, or EU MDR conformity assessment now translates more directly into ANVISA’s expectations than at any prior moment. The historical penalty of duplicating documentation across regions is materially smaller in 2026 than it was in 2022.

The window for “first to file under the new framework” is open. Regulatory teams that align Brazilian submissions with the new convergence framework now will move ahead of teams that wait for further clarification. Once a sponsor has navigated one device through the new SIUD or updated SaMD pathway, every subsequent submission moves faster.

Post-market obligations are being modernized. The new SIUD database is not just a labeling exercise — it forms the backbone of a more sophisticated post-market surveillance regime. Sponsors who structure their data capture and adverse event tracking systems to align with the new SIUD inputs from day one save significant retrofit cost later.

Practical Planning for the Next 12 to 18 Months

Three actions are appropriate for any sponsor with Brazilian exposure or plans:

• Audit your UDI strategy now. If your device class is in the early SIUD phase-in, allocate budget and labeling capacity in 2026. If your device is in a later phase, use the next 12 months to harmonize UDI assignment with the FDA UDI database and the EU EUDAMED framework so all three jurisdictions are covered with a single system.
• Restructure your technical file with convergence in mind. The 2026 reality is that one well-organized technical file should serve FDA, EU MDR, and ANVISA submissions with mostly mechanical translation steps and only modest jurisdiction-specific addenda. If your team is still maintaining three parallel files, the next 12 months are the right window to consolidate.
• Engage early on SaMD classification. If your device incorporates software, AI, or clinical decision support, ANVISA’s updated framework means that a pre-submission classification conversation now yields meaningfully more predictable answers than two years ago. Take advantage of that predictability before launching the trial.

Frequently Asked Questions

Does the new ANVISA convergence framework affect clinical trial submission timelines?
Yes — primarily through Lei 14.874’s parallel review mechanism, which lets ANVISA and ethics committees review submissions simultaneously instead of sequentially. The practical effect is a several-week to several-month reduction in start-up timelines compared with the pre-2025 framework, depending on device complexity.

If my device is FDA-cleared, will ANVISA accept the FDA submission as-is?
Not as-is. ANVISA’s reliance and convergence framework reduces duplication but does not eliminate the need for a Brazil-specific submission. What it does change is that your FDA-aligned technical file, risk classification logic, and clinical evidence package now translate more directly into ANVISA expectations, with smaller jurisdiction-specific gaps to fill.

How does the SIUD database affect sponsors who do not yet sell in Brazil?
If you have no Brazilian commercial presence and no plans for one, SIUD does not directly apply. If you are running a clinical trial in Brazil intending to commercialize there later — or to use Brazilian data in support of a future commercial registration — building UDI alignment into your trial-stage device labeling now is materially cheaper than retrofitting it later.

bioaccess® supports first-in-human and early-feasibility medical device trials across 10 Latin American countries, including Brazil under ANVISA’s modernized framework. Learn more at bioaccessla.com or book a strategy conversation at bioaccessla.com/book-a-meeting.

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Ethics Committee Amendment Cycles in Latin America: How to Protect Your FIH Timeline

When first-in-human (FIH) medical device sponsors benchmark Latin America against the US and EU, they typically focus on initial regulatory approval times. That is the right place to start — ethics committee (EC) approvals in Colombia, Mexico, Brazil, and Chile routinely land in 4 to 8 weeks, compared with 6 to 12 months in the US and EU. But initial approval is only the first checkpoint. What most sponsors underestimate is how EC amendment cycles affect the total timeline once the trial is active.

Across our operational portfolio, amendment handling is where many sponsors lose — or preserve — weeks of study duration. The patterns below come from years of managing EC submissions for FIH medical device studies across the region, anonymized and generalized for this post.

Why Amendments Happen More Often Than Sponsors Expect

FIH studies are inherently iterative. Early safety signals, minor device refinements, protocol clarifications, investigator rotations, and updated informed consent forms all generate amendments. For a typical 10-patient FIH study running 12 months, sponsors should plan for three to six protocol or document amendments during the life of the trial — sometimes more for device studies with embedded software or evolving clinical endpoints.

In the US and EU, each of these amendments often triggers a fresh cycle through the IRB or ethics body, with turnaround times that can stretch from three weeks to several months depending on whether the committee considers the change substantial. Every week a protocol amendment sits in review is a week the site cannot enroll under the new version.

The Amendment Turnaround Advantage in Latin America

Operational data from FIH studies across the region shows a very different cadence. When a well-prepared amendment dossier is submitted to an experienced EC in Colombia, Mexico, or Brazil, approval typically returns in one to three weeks. In several recent studies, amendment approvals have come back in as little as 24 hours to seven days when the change is administrative (site address updates, CV refreshes, minor consent language edits).

Three structural reasons explain the speed difference:

• Higher EC meeting frequency. Many accredited Latin American ethics committees meet weekly or biweekly, compared with monthly cycles at many US academic IRBs.
• Shorter queues. ECs at private hospitals and specialized research centers carry lighter portfolios than large US academic IRBs juggling hundreds of active protocols.
• Tighter sponsor–EC communication. In many LATAM centers, the ethics coordinator and the site principal investigator share an institutional reporting line, making pre-submission clarification conversations possible in ways that rarely happen in the US.

Where Sponsors Still Lose Time — Avoidable Mistakes

The speed advantage is real, but it is not automatic. Three failure patterns consistently slow down amendments in the region:

• Inconsistent document versioning across countries. In multi-country FIH studies, sponsors often submit slightly different amendment packages to different ECs, which generates clarification requests and restarts the clock.
• Missing translation certifications. Several regulators and ECs in the region require certified Spanish or Portuguese translations of English-language source documents. Un-certified translations are a common cause of rejection on first pass.
• Late-stage investigator brochure updates. Sponsors who revise the investigator brochure after starting enrollment often trigger mandatory re-consent of already-enrolled subjects. Planning brochure updates before first patient in — or batching them with other substantial amendments — preserves both timeline and data integrity.

What Founders and Regulatory Directors Should Do

A practical playbook for protecting your FIH timeline during the amendment phase:

• Pre-build an amendment calendar. At study start-up, map out the likely amendments you will need in the first six months — IB updates, consent refinements, site additions — and pre-stage the documents.
• Harmonize across countries from day one. Use identical protocol and consent templates across all participating countries, with only legally mandated local language and regulatory footers differing. This dramatically reduces EC back-and-forth.
• Use a single regulatory project manager across the region. Consistent version control and a single point of submission accountability across Colombia, Mexico, Brazil, Argentina, and Chile eliminates the most common source of delay.
• Budget for translation certification up front. Build certified translation costs into the study budget rather than scrambling during each amendment.

For MedTech founders running a 12-month FIH program, disciplined amendment management is worth roughly two to four weeks of preserved timeline — enough to either move a milestone forward or absorb an unexpected delay elsewhere without slipping the study closeout date. In an industry where 90% of healthcare startups fail because they run out of capital before generating clinical data, those weeks are strategic runway.

Frequently Asked Questions

How long does a typical protocol amendment take in Latin America versus the US?
For experienced ethics committees in Colombia, Mexico, Brazil, Argentina, and Chile, substantial amendments typically receive approval in one to three weeks. Minor administrative amendments can approve in seven days or less. By comparison, US academic IRBs often take four to eight weeks for substantial amendments and two to four weeks for minor ones.

Do all amendments require re-consent of already-enrolled subjects?
No. Only amendments that materially change the risk-benefit profile, introduce new procedures, or alter the primary informed consent elements require re-consent. Administrative changes, site additions, and CV updates do not. A well-designed amendment strategy bundles consent-relevant changes to minimize re-consent events.

Can amendment delays invalidate FDA bridge data from a LATAM study?
No, provided the study remains in compliance with ICH-GCP and 21 CFR 812.28 throughout. What matters for FDA acceptance is that each amendment is properly reviewed, documented, and approved by the responsible ethics committee before implementation — not how long the approval took.

bioaccess® is the world’s only CRO built exclusively for first-in-human clinical trials. We execute FIH and early-feasibility studies across 10 Latin American countries with a 12-month timeline guarantee. Explore our approach at bioaccessla.com or estimate a study at bioaccessla.com/clinical-trial-calculator.

FDA’s December 2025 RWE Guidance and Latin American Clinical Data: A New Strategic Window for Medical Device Sponsors

In December 2025, the FDA finalized an update to its 2017 guidance on the use of real-world evidence (RWE) in medical device regulatory submissions. The revision is narrow on paper but strategically significant: the FDA no longer always requires sponsors to submit or secure access to identifiable individual participant-level data when using real-world data sources to support an IDE, 510(k), De Novo, PMA, or HDE submission. Aggregate, de-identified, and privacy-restricted data sources are now acceptable with appropriate justification.

For MedTech sponsors running first-in-human and early-feasibility clinical trials in Latin America, this shift creates a new strategic window — one worth understanding before your next regulatory conversation with the FDA.

What Changed in the December 2025 Guidance

The 2017 guidance effectively expected sponsors to obtain patient-level records when using real-world data sources — a high bar when the underlying data came from registries, hospital systems, or health databases outside the US that operated under privacy rules limiting sponsor access. The December 2025 revision explicitly acknowledges that reality and redirects the evaluation toward a different question: whether the evidence is scientifically sound and fit for purpose, regardless of whether the sponsor can access every underlying record.

Three practical shifts flow from this:

• De-identified and aggregate datasets are now usable. Sponsors no longer need to demonstrate access to identifiable records when privacy rules forbid it, as long as data relevance, reliability, and traceability are documented.
• International data sources are explicitly addressed. The FDA recognizes that privacy and legal frameworks outside the US (GDPR, Latin American data protection laws, regional privacy statutes) may limit participant-level sharing — and says so directly.
• The burden shifts to transparency. Where participant-level data are unavailable, sponsors must clearly document what data are available, who has access, and how limitations affect the results.

The guidance still applies only to medical devices. The parallel drug and biologics RWE guidance remains unchanged for now, with an FDA statement that updates are under consideration.

Why This Matters for Latin American Clinical Data

Latin America has spent the last decade becoming a practical venue for FIH and early-feasibility medical device trials. The region offers 40% faster regulatory approval timelines, 30% lower overall trial costs, and ethics-committee turnaround of 4 to 8 weeks against 6 to 12 months in the US and EU. Clinical data generated in the region are already accepted by the FDA under 21 CFR 812.28 when ICH-GCP compliance is documented.

What the December 2025 guidance adds is a second, complementary path: real-world evidence sourced from Latin American healthcare systems, registries, and post-market data — data that was previously awkward to incorporate into US submissions because of cross-border privacy restrictions. Under the new guidance, a MedTech sponsor can now more credibly combine:

• A prospective FIH or early-feasibility study conducted under ICH-GCP at accredited Latin American sites, producing the core safety and effectiveness data;
• Supporting real-world evidence drawn from regional hospital registries, payer databases, and post-market surveillance — including aggregate-only sources — to strengthen external validity, capture long-term outcomes, or support indication expansion.

Strategic Implications for MedTech Founders

For founders and regulatory directors planning a device program, the December 2025 revision opens three concrete strategic options:

• Smaller, faster pivotal studies. When aggregate RWE can support effectiveness or safety endpoints, prospective sample sizes can sometimes be reduced, shortening enrollment timelines and cost.
• Stronger post-market commitments. FDA post-market surveillance obligations can increasingly be satisfied with regional registry data and claims-like datasets from Latin American health systems, rather than expensive prospective US post-approval studies.
• Indication expansion without re-running a full trial. When a device is approved for one indication, RWE from real-world use in Latin American hospitals can support label expansion submissions with a much smaller prospective component.

What You Need to Get Right

The FDA is not lowering the scientific bar. The agency explicitly reinforced that relevance and reliability remain the core evaluation criteria. Practically, sponsors planning to use Latin American RWE in a submission should:

• Prespecify the protocol. Define in writing how the RWE data source will be used, what endpoints it supports, and how missing data will be handled — before any analysis runs.
• Document data provenance. Source systems, extraction dates, curation steps, and validation activities must be traceable. When patient-level access is not available, this documentation burden increases.
• Address bias and confounding explicitly. Sensitivity analyses, transparent endpoint definitions, and prespecified analytic assumptions are essential.
• Validate key data elements. Device exposure capture (through UDIs or alternative approaches), clinical outcomes, and covariates must be validated against a gold standard where feasible.

Frequently Asked Questions

Does the December 2025 FDA guidance apply to drug or biologic submissions?
No. The current revision applies to medical device submissions only. The FDA has indicated that it intends to consider parallel updates for drugs and biologics, but those have not been finalized. Drug sponsors should continue to engage the FDA early on a case-by-case basis when proposing RWE approaches.

Can I use a Latin American hospital registry as a real-world data source for an FDA device submission?
Yes, provided the data are relevant to the population, exposure, and outcomes of interest, and reliable in terms of generation, curation, processing, and validation. The December 2025 guidance explicitly accepts aggregate and de-identified data sources when participant-level access is restricted by local privacy law, so long as sponsors transparently document those limitations.

How does this guidance interact with 21 CFR 812.28 for prospective trials?
The two frameworks are complementary. 21 CFR 812.28 governs acceptance of prospective clinical investigations conducted outside the US, requiring ICH-GCP compliance. The December 2025 RWE guidance governs acceptance of real-world data — registries, claims, electronic health records — that are not generated through a prospective clinical trial. A well-designed Latin American regulatory strategy can now use both pathways in a single submission.

bioaccess® is a contract research organization purpose-built for first-in-human and early-feasibility medical device trials, operating across 10 Latin American countries with a 12-month timeline guarantee. Learn more at bioaccessla.com or book a strategy conversation at bioaccessla.com/book-a-meeting.