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 reviews an IDE on a fixed 30-day clock (21 CFR 812.30(a)), and the biggest schedule lever is Pre-Sub alignment. bioaccess quotes each budget per study; 4-8 weeks LATAM ethics review; a protocol-to-first-patient timeline that varies by study (we confirm it per protocol) 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 reviews an IDE on a fixed 30-day clock (21 CFR 812.30(a)) (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 quotes each budget per study; 4-8 weeks LATAM ethics review; a protocol-to-first-patient timeline that varies by study (we confirm it per protocol) 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. 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 quotes each budget per study — planning ranges, not guarantees.
There is no fixed calendar; the biggest schedule lever is Pre-Sub alignment, plus IDE preparation, contracting, IRB review, and enrollment. The FDA reviews an IDE on a fixed 30-day clock (21 CFR 812.30(a)). bioaccess publishes 4-8 weeks for LATAM ethics review and a protocol-to-first-patient timeline that varies by study (we confirm it per protocol) 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