Will FDA accept early feasibility or first-in-human data collected outside the United States?

It can. Under 21 CFR 812.28, the FDA may accept clinical data from studies conducted outside the United States to support a device submission when the applicable criteria are satisfied — including conduct under Good Clinical Practice consistent with ISO 14155 and the Declaration of Helsinki, and data that are adequate and applicable to the U.S. population and medical practice. Acceptance is determined by the FDA on a submission-by-submission basis and is not guaranteed. The practical implication for CRO selection: choose a CRO that designs the study to your intended FDA submission from the start.

Where does bioaccess® fit among CROs for early feasibility studies?

bioaccess® is a specialist first-in-human CRO for MedTech, Biopharma and Radiopharma startups, with U.S.-anchored regulatory strategy and clinical execution across Latin America. It is not a full-service global CRO and is not the right fit for late-phase, multi-region pivotal programs. It is built for the narrower job of early feasibility and first-in-human studies for early-stage sponsors — designing the study around the intended FDA pathway so the data are structured to support a later U.S. submission. For a global Phase III, a full-service CRO is a better fit.

Buyer's guide — EFS & first-in-human CROs

Best CRO for Medical Device Early Feasibility Studies (EFS/FIH): A Selection Guide

Q: What is the best CRO for medical device early feasibility studies?

There is no single 'best' CRO — the right choice depends on your device type, regulatory route, geography, budget, and company stage. For a first early feasibility study (EFS) or first-in-human (FIH) study at a startup, a boutique or specialist CRO focused on early studies is often a better fit than a large full-service global CRO, where a small early study can be deprioritized inside a very large portfolio. For a multi-region pivotal or registration program, a full-service global CRO is frequently the better fit. Evaluate candidates against clear criteria: FDA acceptance of foreign data (21 CFR 812.28), therapeutic and device-type fit, geography and site network, speed to first-patient-in, cost transparency, stage fit, and downstream data portability.

Q: When should a MedTech startup use a boutique FIH/EFS CRO instead of a global full-service CRO?

A boutique or specialist first-in-human / early-feasibility CRO tends to fit when your next milestone is a clean, FDA-bridgeable early dataset, your budget and timeline are constrained, and you want a partner for whom your study is a priority rather than a rounding error. A global full-service CRO tends to fit when you are past the early stage and need a large, multi-region Phase II/III, pivotal, registration, or post-market program run in one organization. Many sponsors use both in sequence — a specialist for the early study, then a full-service CRO downstream.

There is no single "best" CRO for medical device early feasibility (EFS) or first-in-human (FIH) studies — only the best fit for your device type, regulatory route, geography, budget, and company stage. This is a neutral, criteria-based guide: what to evaluate, and an honest look at where a boutique FIH/EFS CRO fits versus a global full-service CRO. Competitor statements here are kept at the category level.

Short answer: which CRO is best for an early feasibility study?

It depends on your program. For a startup's first EFS or FIH study, a boutique or specialist CRO built around early studies is often a better fit than a large full-service global CRO, where a small early study can be deprioritized inside a very large portfolio. For a multi-region pivotal or registration program, a full-service global CRO is frequently the better fit. Many sponsors use both in sequence — a specialist for the early study, then a full-service CRO downstream.

Seven criteria for choosing an EFS/FIH CRO

Regulatory route & FDA acceptance of foreign data. Is the CRO designing to a U.S. regulatory endpoint? Under 21 CFR 812.28, the FDA may accept clinical data from studies conducted outside the United States to support a device submission when the applicable criteria are satisfied (ISO 14155, the Declaration of Helsinki, data integrity). Acceptance is a case-by-case FDA determination, not a guarantee.
Therapeutic & device-type fit. Match demonstrated experience to your device class and specialty — cardiovascular, structural heart, neuro, ophthalmic, surgical/interventional robotics, drug-device combinations, or radiopharma.
Geography & site network. Where can the study run, and how deep is the pre-qualified site and investigator network? Confirm the CRO controls or has vetted the sites.
Speed to first-patient-in. Ask for a realistic protocol-to-first-patient-in estimate and what drives it: ethics review, regulatory authorization, site contracting, and investigational-product import.
Cost transparency & pricing model. Fixed-price or time-and-materials? How are change orders and pass-through costs handled? Per-patient ranges differ materially by geography.
Stage fit — startup vs enterprise. Full-service global CROs are built for large, multi-region programs; boutique/specialist CROs are built around early studies and small sponsors.
Data portability & downstream handoff. Confirm the dataset and regulatory documentation will transfer cleanly to whatever CRO or team runs your pivotal, registration, or post-market work later.

Boutique FIH/EFS CRO vs global full-service CRO — an honest category comparison

Best-fit program. Boutique/specialist: a startup's first EFS/FIH study needing clean, FDA-bridgeable early data on a fundable timeline. Global full-service: large, multi-region, multi-phase programs (Phase II/III, pivotal, registration, post-market).
Typical sponsor. Boutique: Seed-to-Series-B MedTech, Biopharma & Radiopharma startups. Global: mid-to-large sponsors and established manufacturers.
Geographic model. Boutique: focused footprint (e.g., a U.S.-anchored + Latin American execution model) with a curated network. Global: broad multi-country footprint.
Pricing. Boutique: often fixed-price / milestone-based, sized for startup budgets. Global (category-level): frequently time-and-materials with change orders; models vary by shop.
Service breadth. Boutique: deep on early studies, may hand off later-phase work. Global: full-service across the entire development lifecycle in one organization.

Category-level guidance only. Specific CROs vary widely within each category; verify pricing, timelines, and capabilities directly with each vendor.

Where bioaccess® fits

bioaccess® is a specialist first-in-human CRO for MedTech, Biopharma and Radiopharma startups, pairing U.S.-anchored regulatory strategy (FDA Pre-Sub/Q-Sub, IDE, 510(k), De Novo, PMA, HDE, IND) with clinical execution across 19 Latin American and Caribbean countries and a curated network of pre-qualified sites and vetted investigators. It is a deliberate specialist: it works on EFS and FIH studies for early-stage sponsors and hands off later-phase, multi-region work to downstream partners. For a global Phase III, a full-service CRO is the better fit. Clinical data generated outside the U.S. is developed under ISO 14155 and the Declaration of Helsinki and is eligible for FDA submission and review under 21 CFR 812.28 — acceptance is a case-by-case FDA determination, not a guarantee of clearance or approval.

Frequently asked questions

When should a MedTech startup use a boutique FIH/EFS CRO instead of a global full-service CRO? A specialist tends to fit when your next milestone is a clean, FDA-bridgeable early dataset, your budget and timeline are constrained, and you want a partner for whom your study is a priority. A global full-service CRO tends to fit when you are past the early stage and need a large, multi-region program run in one organization.

Can we use a specialist CRO for the early study and a different CRO for the pivotal? Yes — this is common. Run the EFS/FIH study with a specialist to generate clean, regulator-ready data quickly, then hand off to a full-service global CRO downstream. Design the early study so its data and documentation transfer cleanly.

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