First-in-human without waiting years for FDA: the LATAM evidence calendar vs the U.S. IDE clock

The question boards keep asking is not “how long is an FDA IDE review.” It is “how do we get first-in-human data without waiting years for FDA.” The 30-day IDE clock is rarely the year that eats the raise. The year is domestic site contracting, IRB sequencing, and the decision to treat first patient as a United States-only problem.

A Latin America first-in-human (FIH) or early feasibility study (EFS) is not a shortcut around FDA. It is a second calendar that can put ISO 14155 evidence in the room while the U.S. path is still being built. Design it for 21 CFR § 812.28 from day one, or you bought speed you cannot spend later.

What “without waiting for FDA” actually means

It does not mean “skip FDA.” It means stop treating first-in-human as identical to “first U.S. IDE subject.” For a Class III implantable or a novel Class II device, the practical split looks like this:

• Evidence calendar: first patient under a Latin America investigation authorization, with GCP, independent ethics, investigational labeling, and a trial master file you can hand an FDA reviewer.
• U.S. marketing calendar: IDE, 510(k), De Novo, or PMA workstreams that can use those foreign data when § 812.28 is met — eligibility is not clearance.
• Commercial calendar: country-by-country registro / holder / IOR files. A Panama FIH does not create an INVIMA, ANVISA, or COFEPRIS selling license. Keep that track off the investigation critical path until you mean it. The live market-access hub and the holder vs IOR comparison already separate those desks.

If your Gantt has one bar labeled “regulatory,” you do not have a plan. You have a hope.

Where U.S. startups already run the parallel calendar

bioaccess® publishes Panama and El Salvador as lead FIH jurisdictions for device investigations that must later talk to FDA:

• Panama. Class III FIH under MINSA and the Comité Nacional de Bioética de la Investigación (CNBI), on Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C). The live Panama Class III FIH guide already names parallel high-risk review, a 20-business-day ordinary ethics cap, and SAE clocks of 24 hours / 15 days. Dollarized economy. English-capable sites. Investigation units only — not a registro SKU on the airway bill.
• El Salvador. CNEIS ethics plus SRS clinical-investigation authorization on a published 30–60 day study-startup band. That band is not a DNM/SRS commercial registro. The sibling post on CNEIS/SRS trial vs DNM registro exists because sponsors keep merging the two clocks.

Paraguay (DINAVISA) appears on the same ISO 14155 + § 812.28 execution list on the holder page. Country choice is a dossier and site decision, not a slogan. Colombia remains a strong market-access and historical FIH geography for bioaccess®, but the public Colombia hub is not a blanket “start your next first-in-human here” recommendation for every new device — pick the jurisdiction whose ethics desk, import path, and site capacity match the protocol you actually wrote.

What FDA will ask later (design it now)

§ 812.28 is the acceptance rule for clinical investigations conducted outside the United States. In short, FDA expects a well-designed, well-conducted investigation, independent ethics review and informed consent, and a device comparable to the version you will put in the U.S. file. FDA has stated that conformance with ISO 14155:2020 will generally satisfy the GCP piece of that rule — already footed on the Panama FIH guide and the after-first-patients sequencing post.

Practical consequences before first patient:

1. Same device story. The investigational article, accessories, and labeling must map to the U.S. design you intend to defend. A “Panama-only” SKU that diverges from the IDE article creates a comparability problem, not a speed win.
2. Inspectable file. Monitoring reports, device accountability, deviation logs, ethics correspondence, and the Spanish informed-consent version history in one place. A clean investigation letter is not a trial master file.
3. Importer named for investigation units. Do not put a cousin commercial registro number on FIH freight. That pattern burns weeks at customs and contaminates both tracks.
4. Success criterion written as evidence, not as “FDA approved.” First patient and a closed ISO 14155 package are the FIH win. Clearance is a later petition.

After first patients is a different question

Once you have subjects, the sequencing problem flips from “how do we start” to “how do we spend the data.” The live after-first-patients article already says the job is not “FDA then LATAM.” Sequence the same dataset toward the U.S. marketing path and toward the commercial countries you actually intend to sell — they are different petitions. A Panama or El Salvador investigation does not travel as an ANVISA or COFEPRIS registro. Pick the commercial four (or a subset) and open those holder files when launch is real, not when the PI asks for leftover kits.

One-page gate before you book sites

Write owners and document IDs before initiation visits:

1. Question on the board. “Human data for the raise / next FDA meeting” is an evidence ask. “Sell in Colombia in Q4” is a registro ask. Do not fund them from one workstream.
2. Lead FIH jurisdiction. Panama MINSA/CNBI, El Salvador CNEIS/SRS, or another published desk — with the governing decree or platform named, not a country flag on a slide.
3. § 812.28 owner. Who can produce the GCP package within 48 hours if FDA asks.
4. Investigational importer and device list. Every unit that will sit in site accountability.
5. Commercial holder (optional, separate). Only if a real launch country is in scope this year. Use the market-access track; do not hang it on the FIH critical path.

Where teams burn the year anyway

• Waiting for a U.S. site that is “almost ready.” Almost ready is not first patient. A parallel LATAM investigation can run while the U.S. contracting stack finishes.
• One Gantt bar for FIH and registro. Trial authorization and sanitary registration share clock language in several LATAM markets. They do not share a dossier. El Salvador’s 30–60 day language is the clearest public example.
• Foreign data with a thin TMF. Speed without ISO 14155 discipline buys a story investors like and reviewers will not.
• Country tourism. Opening five ethics desks because a slide said “LATAM” dilutes the file. One strong investigation beats five thin ones.

Practical next step

This week, rewrite the board slide. Column one: FIH/EFS jurisdiction, ethics desk, investigation importer, § 812.28 owner. Column two: U.S. IDE or marketing path. Column three: commercial holder countries, if any. If column one is empty because “we are waiting on FDA,” you are waiting on the wrong clock. bioaccess® runs FIH/EFS execution across Latin America from Miami — with Panama and El Salvador as published lead investigation hubs — and keeps LATAM registration/IOR on a separate market-access track. Start from the Panama Class III FIH guide or the El Salvador clinical-trials hub for the evidence column, and keep the market-access hub out of the first-patient critical path until you mean to sell.