U.S. Early Feasibility Support for Medical Devices — bioaccess®

What does bioaccess® do for U.S. early feasibility? We support FDA EFS strategy and Pre-Submission planning from Miami — helping you align with the FDA on risk, testing, and mitigation before the IDE is written. Our affiliated site, Amavita Research in Miami, participates in cardiovascular device studies when the device and the study fit. And we give you an honest recommendation on geography: a U.S. EFS when early FDA interaction matters most, a Latin American FIH when activation speed and enrollment throughput are the binding constraints — with data engineered from day one to support your FDA pathway under 21 CFR 812.28. We do not operate a U.S. hospital site network, and we won’t pretend otherwise: our proven execution footprint is first-in-human and early-feasibility studies across 19 Latin American and Caribbean countries.

What we do in the United States

• EFS strategy and Pre-Submission planning (Miami) — program-fit assessment, Pre-Sub content strategy, and the risk-and-evidence rationale the FDA expects before the IDE is written.
• Pre-Sub meeting preparation (Miami) — device description, clinical context, and testing expectations aligned with the agency.
• IDE-readiness review (Miami) — a second set of eyes on the risk analysis, the nonclinical testing package, and clinical risk-mitigation measures (site selection, monitoring, stopping rules).
• Geography decision: U.S. EFS or Latin America FIH — a structured recommendation made before anyone commits to a geography.
• Amavita Research (Miami) — affiliated cardiovascular site participation when the device and study fit; site participation for the right studies, not a U.S. site network.

What we don’t do

• We do not operate a U.S. hospital site network. If your program needs a U.S. site-management organization, we will say so — and we can still support the Pre-Submission.
• We do not sell one geography. The recommendation follows what your program needs, not what we want to sell.
• We are not the only early-feasibility specialists. MMC Medical International Consulting has focused on first-in-human device studies since 1992; NAMSA, Avania, and Medpace run FIH and EFS work within broader service menus.

How an engagement works

1. Program review — device, development stage, what the early study must prove.
2. Geography recommendation — U.S. EFS, Latin America FIH, or a sequenced combination, in writing, before any commitment.
3. Pre-Sub strategy and planning — if the U.S. path fits, from Miami.
4. Execution, wherever it belongs — Latin America FIH across 19 countries by bioaccess®; U.S. EFS supported through IDE submission with honest guidance on site partners where we don’t operate.

This page is general information, not regulatory advice; confirm your specific pathway with the FDA, ideally via a Pre-Submission.

FDA EFS program guide · EFS in Latin America · FDA acceptance of OUS data · Book a strategy call

Founder perspective

A MedTech founder's scarcest resources are time and runway. By anchoring the regulatory strategy in the U.S. and running the first-in-human study across Latin America, our clients reach human data meaningfully faster and at a lower per-patient cost than a U.S. or EU program — with GCP-compliant (ISO 14155) data quality supporting eligibility for FDA acceptance under 21 CFR 812.28. Individual timelines and costs vary and are not guaranteed.