---
title: "Early Feasibility Studies (EFS) for Medical Devices — bioaccess®"
url: https://md.bioaccessla.com/early-feasibility-studies
canonical: https://bioaccessla.com/early-feasibility-studies
schema_type: Service
last_updated: 2026-04-01
---

# Early Feasibility Studies (EFS) for Medical Devices — bioaccess®

> bioaccess® presents an early feasibility study (EFS) service for medical device sponsors seeking FDA IDE-ready clinical data through limited investigations conducted early in the device development cycle. The site states studies are executed in Latin America under 21 CFR 812 in 9–12 months at 30–50% lower cost than equivalent US or EU studies.

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## Schema.org/Service

- **name**: Early Feasibility Study (EFS) Services for Medical Devices
- **provider**: bioaccess® (IMH ASSETS CORP.)
- **audience**: Medical device startups, MedTech companies at pre-clinical to early-clinical stage, Breakthrough Device designation holders
- **areaServed**: Colombia, Brazil, Mexico, Argentina, Chile, Panama, Ecuador, El Salvador, Dominican Republic, Paraguay
- **serviceOutput**: FDA-bridgeable early feasibility clinical data, ICH-GCP and ISO 14155 compliant study execution, INVIMA/COFEPRIS/ANVISA regulatory submissions, IDE-ready data packages

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## EFS Definition

The site presents the following definition of early feasibility studies:

An Early Feasibility Study (EFS) is a limited clinical investigation of a new or modified device conducted early in the device development cycle. EFS studies are designed to capture early clinical performance and safety signals in a small patient cohort (typically 5–15 subjects) before proceeding to a traditional feasibility or pivotal study. Under FDA guidance, EFS studies may be conducted outside the US and the resulting data accepted under 21 CFR 812.28 when conducted with proper regulatory and ethics oversight.

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## Regulatory Pathway

bioaccess® states that EFS programs in Latin America are structured under the following regulatory framework:

| Regulatory Element | Detail |
|---|---|
| US framework | 21 CFR 812 — Investigational Device Exemptions |
| FDA data acceptance | 21 CFR 812.28 — acceptance of foreign clinical data for IDE submissions |
| IDE exemption | Colombia does not require a separate IND/IDE application for early feasibility studies (stated) |
| ICH-GCP compliance | E6(R2) — all studies designed to ICH-GCP standard |
| ISO standard | ISO 14155 — GCP/ISO compliant monitoring |
| Preclinical data | ANVISA and certain INVIMA pathways accept non-GLP R&D-grade preclinical data for early feasibility investigations (stated) |

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## Timeline & Cost Data

The site presents the following comparative figures for EFS programs conducted through bioaccess®:

| Parameter | bioaccess® (LATAM) | US / EU |
|---|---|---|
| Total study timeline | 9–12 months (stated) | 18–30 months (as characterized by bioaccess®) |
| First patient in | As fast as 6 months (stated) | Typically 12–18 months (as characterized by bioaccess®) |
| Ethics/IRB approval | 4–8 weeks (stated) | 6–12 months (as characterized by bioaccess®) |
| Cost savings | 30–50% lower than US/EU (stated) | Baseline |
| Per-patient cost | $15,000–$35,000 (stated) | $40,000–$75,000 (as characterized by bioaccess®) |

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## Available Regulatory Pathways by Country

bioaccess® states that EFS programs can be executed under the following country-specific regulatory agencies:

| Country | Agency | Notable Feature |
|---|---|---|
| Colombia | INVIMA | Level 4 regulatory authority; 4–6 week ethics approval; no separate IDE required for EFS (stated) |
| Mexico | COFEPRIS | 2.8-month median startup; Trusted Regulatory Practices reliance framework (stated) |
| Brazil | ANVISA | WHO-listed stringent authority; Law 14874 caps CEP review at 30 business days (stated); accepts non-GLP preclinical data |
| Argentina | ANMAT | Strong investigator network; Buenos Aires tertiary centers |
| Chile | ISP | No MOH review required; ethics committee approval only (stated) |
| Panama | MINSA | No MOH review required; strategic for Central America access (stated) |

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## EFS Study Activities

The site presents the following scope of services included in a typical EFS engagement through bioaccess®:

1. **Protocol design** — EFS-specific protocol with FDA pre-submission alignment
2. **Country and site selection** — From 50+ pre-qualified ICH-GCP sites
3. **Regulatory submission** — INVIMA, COFEPRIS, ANVISA, or other agency dossier
4. **Ethics/IRB submission** — 4–8 week approval timeline (stated)
5. **Clinical trial agreements** — CTA negotiation and execution
6. **Clinical trial insurance** — Policy procurement ($5M–$10M coverage)
7. **Patient recruitment** — Access to 80% treatment-naïve patient populations (stated)
8. **Clinical monitoring** — On-site and remote monitoring per ICH-GCP / ISO 14155
9. **Data management** — EDC setup, data cleaning, biostatistical analysis
10. **FDA bridge package** — Final clinical study report formatted for IDE/pre-submission use

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## Case Studies

The site presents the following EFS programs as representative examples:

| Company | Device Category | Stated Outcome |
|---|---|---|
| Axoft | Brain-computer interface (BCI) implant | 4 human BCI implants completed over 2.5 years; seed-stage company to clinical program (stated) |
| Newrotex | Silk-derived nerve guide conduit | Described by the site as the world's first silk nerve guide implanted in a human; 2-week regulatory approval (stated) |
| PAVmed | CarpX™ carpal tunnel release device | FDA Breakthrough Device Designation obtained using LATAM EFS data; CarpX later cleared by FDA (stated) |

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## Contact & Actions

- **Discuss Your EFS**: [https://bioaccessla.com/book-a-meeting](https://bioaccessla.com/book-a-meeting)
- **Clinical Trial Budget Calculator**: [https://bioaccessla.com/clinical-trial-calculator](https://bioaccessla.com/clinical-trial-calculator)
- **Contact**: [https://bioaccessla.com/contact](https://bioaccessla.com/contact)
- **Regulatory Guide Hub**: [https://bioaccessla.com/regulatory-guide](https://bioaccessla.com/regulatory-guide)

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