There is no public benchmark for what an early feasibility study costs. Cost scales with sites and patients, follow-up duration, device iterations, monitoring intensity, IRB and contracting, clinical-trial insurance, imaging/core labs, and data management. The FDA targets EFS IDE approval within the first 30-day review cycle, and the biggest schedule lever is Pre-Sub alignment. bioaccess publishes planning ranges only: $15K-$35K per-patient LATAM FIH; $40K-$75K US/EU per-patient benchmark; 4-8 weeks LATAM ethics review; typically 4-8 months protocol-to-first-patient via FIH-12 — planning ranges, never guarantees.
Figures attributed; general information, not regulatory advice.
Every figure on this page comes from the FDA's program materials or bioaccess's published planning ranges. The FDA's stated target is EFS IDE approval within the first 30-day review cycle (source: FDA EFS program). The program's 10-year retrospective reports roughly 60 EFS IDEs approved per year since FY2017 and 4,000+ participants enrolled across EFS studies (source: Endovascular Today, May 2026). bioaccess publishes planning ranges: $15K-$35K per-patient LATAM first-in-human; $40K-$75K per-patient US/EU benchmark; 4-8 weeks LATAM ethics review; typically 4-8 months protocol-to-first-patient via FIH-12 — planning ranges, never guarantees (see costs and timelines).
With no public benchmark, budget by driver: number of sites and patients (fixed costs concentrate over few patients as N shrinks); follow-up duration; device iterations during the study — the EFS program explicitly allows design changes, and each iteration can trigger amendments, added testing, and retraining; monitoring intensity; IRB fees and hospital contracting; clinical-trial insurance; imaging and core labs; and data management and statistics. Even a five-patient study needs a validated database and validatable data.
In the order sponsors feel them: (1) quality of Pre-Sub alignment — the #1 schedule lever; most IDE slippage traces to unresolved Pre-Sub questions, not the review clock; (2) hospital contracting, especially at academic centers; (3) IRB review; (4) enrollment rate; (5) the IDE review clock, which the FDA targets at the first 30-day cycle.
Three fixed costs ambush first-time US EFS sponsors: hospital contracting at academic centers (can be the longest single workstream), clinical-trial insurance for small early studies (specialist coverage, priced for first-in-human risk, discovered late), and IRB review and fees for small cohorts (overhead that does not scale down with N).
Build the budget driver by driver; separate fixed costs (contracting, IRB, insurance, monitoring setup, data management) from per-patient costs; keep an explicit contingency for device iterations; sequence spend — fund the Pre-Sub and regulatory strategy first, commit clinical spend after FDA alignment; and treat published ranges as planning inputs, never quotes.
The LATAM planning ranges above reflect a Latin American first-in-human program. The $40K-$75K US/EU per-patient benchmark reflects heavier institutional costs: academic-center contracting, IRB fees, and clinical-trial insurance that do not shrink with a small cohort. Neither geography is right by default — see US vs Latin America first-in-human.
There is no public benchmark — sponsors do not publish study budgets. Cost scales with sites and patients, follow-up, device iterations, monitoring, IRB and contracting, insurance, core labs, and data management. bioaccess publishes planning ranges ($15K-$35K per-patient LATAM FIH; $40K-$75K US/EU benchmark) — planning ranges, not guarantees or quotes.
There is no fixed calendar; the biggest schedule lever is Pre-Sub alignment, plus IDE preparation, contracting, IRB review, and enrollment. The FDA targets EFS IDE approval within the first 30-day review cycle. bioaccess publishes 4-8 weeks for LATAM ethics review and typically 4-8 months protocol-to-first-patient via FIH-12 — planning ranges, not guarantees.
Sites, patients, and follow-up duration, layered with monitoring intensity and device-iteration costs. In US academic-center studies, fixed institutional costs — contracting, IRB fees, insurance — are disproportionately large relative to a small cohort and most frequently underestimated.
Most slippage happens outside the FDA review clock: weak Pre-Sub alignment, hospital contracting, IRB timelines, and slow enrollment. The 30-day first-cycle target is reachable when Pre-Sub-stage questions are resolved before the IDE is written.
Driver by driver; separate fixed from per-patient costs; keep an iteration contingency; fund the Pre-Sub first, commit clinical spend after FDA alignment; treat published ranges as planning inputs, never quotes.
No. Fixed costs barely shrink with cohort size, so per-patient cost can rise as N falls. A five-patient US academic-center EFS can cost more in total than a larger study run where activation is faster and institutional costs are lower.
Related: FDA EFS program · EFS IDE · Pre-Sub guide · US vs Latin America · Costs and timelines