US MedTech founders ask this in almost every Panama or El Salvador first-in-human (FIH) scoping call: “If we run the early cases outside the US, will FDA take the data for an IDE, 510(k), De Novo, or PMA?”
I am Julio Martinez-Clark, CEO of bioaccess®. Short answer: yes, foreign clinical data can support those files — when you design the study for 21 CFR 812.28 from day one. A fast ethics letter on the wrong protocol is not an FDA asset. This page is the operator cut for Panama and El Salvador. It sits next to our Panama FIH Class III guide, the LATAM vs Australia early-feasibility comparison, and the early feasibility vs pivotal brief. Not a quote and not legal advice.
One-sentence answer
Panama or El Salvador FIH data can enter an FDA strategy when the investigation meets the good clinical practice (GCP) and supporting-information rules in 21 CFR 812.28 — including an inspectable trial file — and when the investigational device is identical to the US device or you submit a detailed comparison.
What 21 CFR 812.28 actually tests
FDA’s foreign-clinical-data rule is not a country whitelist. It asks whether the investigation was conducted under a GCP standard for design, conduct, monitoring, auditing, recording, analysis, and reporting that keeps data credible and protects subjects. That standard includes independent ethics-committee review and approval before initiation, continuing review, and documented freely given informed consent.
FDA has stated that conformance with ISO 14155:2020 will generally satisfy the GCP requirement of 812.28. Investigations initiated on or after 21 February 2019 must conform to the 2018 foreign-data framework. Country of conduct is relevant for import, ethics, and site quality. It is not a substitute for 812.28 design.
Significant-risk devices: build the full 812.28(b) set
For a significant-risk device as defined in 21 CFR 812.3(m) — the Class III / high-risk biomaterial FIH case — plan the full supporting set in 812.28(b):
- Investigators and sites
- Protocol and results
- A statement that the investigational device is identical to the US device, or a detailed comparison of differences
- Valid scientific evidence under 21 CFR 860.7 if you claim safety and effectiveness
- Independent ethics committee (IEC) identity meeting 812.3(t)
- Consent, monitoring, and investigator GCP training documentation
FDA can validate the data through an onsite inspection or other appropriate means. A Panama or El Salvador file that cannot be inspected is not an 812.28 file. Electronic data capture, device accountability, and source documents that survive an English-speaking inspector are part of study design — not a later translation job.
Do not plan to live in 812.28(e)
Section 812.28(e) is the residual clause: even when a foreign study does not fully meet paragraph (a), FDA may still accept the information if it believes the data are credible and accurate and that subject rights were adequately protected. That is a reviewer safety valve. It is not a protocol strategy. Build paragraph (a). Treat (e) as the exception you hope never to need.
Why Panama and El Salvador show up in the same answer
Both countries are used for early device cohorts when sponsors need surgical or hospital volume outside a US IDE queue. Panama’s investigational desk runs under Ley 84 of 2019 and Decreto Ejecutivo No. 21 of 2026 (CNBI-accredited Type II ethics, RESEGIS, parallel MINSA review for higher-risk protocols). El Salvador is often the second country in a multi-country early plan when enrollment or anatomy needs a wider net — the same pattern already described on our Panama FIH guide (Panama plus El Salvador plus Brazil as an example multi-country frame).
For FDA usability, the country pair matters less than whether both sites run one protocol, one monitoring plan, one device configuration, and one TMF standard. Two local “quick starts” with divergent ICFs and unaccounted devices will not stitch into an 812.28 package later.
What makes OUS data fail the FDA conversation
- Protocol written for local approval only, with inclusion, imaging, and device deficiencies redefined after the fact for a US file
- Investigational configuration that quietly differs from the US device without a comparison table
- English-only or incomplete source that cannot support inspection
- Mixing commercial registro (Panama DNDM / Ley 90–Decreto 490) with the trial authorization and assuming market clearance equals clinical evidence
- Hoping 812.28(e) will rescue a study that never ran ISO 14155 discipline
Operator checklist before first patient in Panama or El Salvador
- Write the US intended use and device configuration on one page. Lock whether the OUS unit is identical or document every difference.
- Design the protocol once for ISO 14155:2020 monitoring, consent, and SAE clocks — then map local ethics and ministry steps underneath it.
- Confirm ethics committees meet the independence expectations behind 812.3(t) and keep approval letters in the TMF.
- Build EDC, device accountability, and source so an FDA inspector can follow a subject without a scavenger hunt.
- Keep commercial registro off the FIH critical path. Trial authorization is not a license to sell.
Talk with bioaccess® when you need a Panama or El Salvador FIH framed so the same dataset can later support an IDE conversation or a marketing submission under 21 CFR 812.28 — without inventing a country whitelist FDA does not publish.
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