Every few weeks a medtech founder shows me the same slide. On the left, a US early feasibility study. On the right, a first-in-human study in Latin America. Under each one, a single number: months to first patient. The slide is almost always wrong, and not because the numbers are made up. It is wrong because it compares one clock in the US with a different clock in Latin America.
I’m Julio Martinez-Clark, CEO of bioaccess®. We have run first-in-human and early feasibility work in Latin America since 2010, and our sister organization Amavita Research runs a cardiovascular site in Miami. This is the calendar I walk founders through when they are deciding where to put their first human cases, and what it takes for that data to count at FDA later.
The short answer
A Latin American first-in-human study is usually faster to first patient than a US early feasibility study when three things are true: the country is chosen for its ethics and import pathway, the protocol is written for 21 CFR 812.28 from day one, and the device can be shipped and held legally in that country. When any of those three is missing, the advantage shrinks fast. A US early feasibility study is the better choice when your next FDA interaction depends on iterating the device with FDA in the room, or when your investors need US sites on the record.
Where the US early feasibility clock actually goes
FDA’s review of an IDE application is not the slow part. Under 21 CFR 812.30(a), FDA has 30 days to approve, approve with conditions, or disapprove an IDE. FDA’s 2013 guidance on IDEs for early feasibility studies, including certain first-in-human studies, was written to let sponsors start with less nonclinical data than a pivotal IDE would need. On paper, that is a fast lane.
The time goes elsewhere:
- Pre-submission work. Most teams run at least one Q-Submission before filing. Scheduling, preparing and digesting FDA feedback adds months before the 30-day clock even starts.
- Approval with conditions. Conditional approvals are common for first studies. Each round of responses is another cycle.
- IRB and institutional review. Academic centers often stack a scientific review, a conflict-of-interest review and an IRB review in sequence.
- Contracts and budgets. Clinical trial agreements at large hospitals move through legal, finance and research administration teams that are serving dozens of sponsors at once.
- Site activation. Device shipment, training, cath lab or OR scheduling and the site initiation visit only start after all of the above.
Founders regularly tell us they planned for six months and lived through a year or more before the first enrolled subject. None of those steps is broken on its own. They are just sequential, and each one belongs to a different organization with its own queue.
Where the Latin American first-in-human clock goes
There is no single Latin American clock. Panama, Costa Rica, Chile, El Salvador, Brazil, Mexico, Argentina and Colombia each have their own ethics and regulator stack. What makes the faster countries faster is structural: in several of them, the ethics committee is the decisive gate for many early device studies, and the ministry step is either light or runs in parallel.
When the file is complete, our planning bands look like this:
- Ethics review: roughly 4 to 8 weeks in the faster pathways, longer when the committee meets monthly and the first submission draws questions.
- Submission to first patient: roughly 3 to 8 months, with Panama often at the shorter end when the dossier, import and site plan are ready on day one.
Those are planning bands from our own programs, not promises for your protocol. Two cautions. First, translation and import are part of the clock, not a side task. A first-in-human implant or catheter has to clear customs under an importer of record who is allowed to hold it. Second, country choice changes over time. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new first-in-human execution, even though Colombia remains a strong market-access country.
Cost is a runway question, not a line item
Per-patient procedure cost in Latin America is often materially lower than in the US. We have written about the drivers in detail in how much a first-in-human trial costs in Latin America vs the United States, so I won’t repeat the bands here.
The number that matters more to a seed or Series A company is months of runway burned before the first human data point. A study that starts five months earlier gives you five months of data before your next raise. A cheaper study that FDA later treats as exploratory and asks you to repeat is not cheaper. It is a second study.
Making the data count: 21 CFR 812.28 in practice
FDA can accept data from clinical investigations conducted outside the US to support an IDE, 510(k), De Novo or PMA. The rule that governs this is 21 CFR 812.28, which applies to investigations that started on or after 21 February 2019. It does not care which country you chose. It cares how the study was run.
In practice, that means:
- A good clinical practice standard. The study must follow GCP for design, conduct, monitoring, auditing, recording, analysis and reporting, including independent ethics committee review before initiation and documented informed consent. FDA has said conformance with ISO 14155:2020 will generally satisfy this.
- Supporting information. For significant-risk devices, plan the full 812.28(b) set: investigator and site details, protocol and results, a statement that the device is identical to the US device or a detailed comparison, ethics committee details, consent and monitoring records, and investigator training.
- Inspectability. FDA may validate the data through an onsite inspection. Source documents, device accountability logs and EDC audit trails must hold up in front of an English-speaking inspector.
There is a residual clause in 812.28(e) that lets FDA accept data that does not fully meet the GCP requirement if it is still credible and subjects were protected. Do not design around it. We cover the details in our note on FDA inspectability of foreign clinical trials under 21 CFR 812.28.
One more practical point: talk to FDA before you start the Latin American study, not after. A Q-Submission that shows FDA your plan for foreign data, your endpoints and your bridge to a US study is the cheapest insurance you can buy.
A side-by-side calendar
Here is how I sketch the two paths for a typical cardiovascular or peripheral device founder. Your protocol will move these bars.
- Month 0 to 2. US: Q-Submission prepared and scheduled. Latin America: country selected, protocol adapted for 812.28 and local rules, translation started, importer of record identified.
- Month 2 to 4. US: Q-Submission feedback, IDE drafted and filed, 30-day review. Latin America: ethics and, where required, regulator submissions in review; site contract signed; import permit requested.
- Month 4 to 8. US: approval with conditions answered, IRB and contract cycles at the first academic site. Latin America: approvals in hand, device cleared through customs, site initiated, first patients treated.
- Month 8 onward. US: first sites activating. Latin America: follow-up data accumulating and feeding the US IDE or the next FDA meeting.
When the US early feasibility study is the better call
I tell founders to stay in the US when:
- The device is likely to change after the first few cases and you want FDA’s interactive early feasibility process to absorb those changes in real time.
- The indication is rare enough that no Latin American site will see the patients you need.
- Your lead investors or acquirers have said they will only value US data at this stage.
- You cannot fund the in-country structure (importer of record, local representative, translated quality documents) that a Latin American study needs.
The hybrid most of our sponsors end up with
The pattern we see most often is not either-or. It is a short first-in-human cohort in Latin America, designed under 812.28, followed by a US early feasibility or pivotal step with that data in the IDE. For cardiovascular devices, Amavita Research in Miami can serve as the US arm while bioaccess® runs the Latin American arm under one protocol and one sponsor counterpart.
That structure keeps the speed of the first human cases and puts US sites on the record before the pivotal conversation.
Questions to answer before you pick a country
- Which FDA submission will this data support, and has FDA seen the plan?
- Is the device we will implant identical to the US device, or do we need a documented comparison?
- Who will be the importer of record, and are they allowed to hold an investigational device?
- Which ethics committee will review, how often does it meet, and in what language does it want the file?
- Can the site’s source documents and device logs survive an FDA inspection?
- What is our follow-up schedule, and does the site have the patients and staff to keep it?
I talk through these trade-offs with founders on Global Trial Accelerators™, our podcast, because the same questions come up in almost every early clinical plan.
If you are sketching your first-in-human plan now and want to know which Latin American countries fit your protocol, send the synopsis through bioaccessla.com and we will reply with the countries that fit and the ones that don’t. If yes, just reply here.