FDA Early Feasibility Study (EFS) Program: The Complete Guide — bioaccess®
What is the FDA Early Feasibility Study program? The FDA Early Feasibility Study (EFS) program is the FDA's pathway for studying a medical device early in development in a small number of subjects — assessing initial clinical safety and device functionality while the design may still change. The path runs through a Pre-Submission (align on risk, testing, and mitigation with the FDA) to an IDE, with the agency targeting approval in the first 30-day review cycle. EFS is not the same thing as first-in-human: FIH marks first clinical use anywhere, while EFS is the FDA's mechanism for early, limited, iterative clinical evaluation. Official program page: FDA — Early Feasibility Studies.
Program figures (about 60 IDEs/year, 4,000+ participants) are as reported in the program's 10-year retrospective (Endovascular Today, May 2026). This page is general information, not regulatory advice.
What counts as an early feasibility study
A limited early study — typically a small number of subjects; assesses initial clinical safety and device functionality, not pivotal effectiveness.
The device may still change — design need not be finalized; clinical experience may inform modifications before traditional feasibility and pivotal stages.
Applies across pathways — EFS studies may support devices headed for PMA, 510(k), De Novo, or HDE. An EFS may sometimes begin with less nonclinical evidence when clinical risk-mitigation measures suffice.
Not U.S.-only by default — the FDA recognizes the value of multigeography and global studies; geography selection should weigh investigator access, infrastructure, EFS/FIH experience, recruitment and follow-up, insurance, cost, and data acceptance.
The EFS path: from first contact to IDE
1. Contact the EFS program representative — discuss whether your device and development stage fit the program before writing anything formal.
2. Submit a Pre-Submission (Pre-Sub) — describe the device, clinical context, and EFS rationale; align on the clinical plan with the FDA.
3. Align on risk, testing, and mitigation — agree on the risk analysis, nonclinical testing needed, and clinical risk-mitigation measures (site selection, monitoring, stopping rules).
4. Submit the IDE — file the investigational device exemption incorporating the Pre-Sub agreements; the program targets approval within the first 30-day review cycle.
EFS by the numbers
2014 — program launched (final guidance issued October 2013)
~60 — EFS IDEs approved per year since FY2017, per the 10-year retrospective
4,000+ — participants enrolled across EFS studies since tracking began
30 days — the FDA's target for EFS IDE approval within the first review cycle
Where sponsors get stuck
Testing expectations: agreeing with the FDA on how much nonclinical evidence is enough before first clinical use
Clinical-trial insurance for small early studies at U.S. hospitals
Hospital contracting timelines at academic medical centers
Budgeting and fair-market-value interpretation for early-stage work
Ethics-review (IRB) costs for small-cohort studies
Indemnification terms between sponsors, sites, and institutions
EFS 2.0 and multigeography studies
The FDA is moving toward "EFS 2.0" — a next phase shaped by ten years of experience — including recognition of the benefit of multigeography and global studies rather than insisting every early study run on U.S. soil.
U.S. EFS or Latin America FIH?
Choose a U.S. EFS when early, iterative FDA interaction is the priority, U.S. investigator and site experience matters for later pivotal work, or investors/acquirers value a U.S.-conducted early study.
Choose Latin America FIH when activation speed and enrollment throughput are the binding constraints, you need first clinical data before committing to a U.S. IDE study, or the data is engineered from day one to come home under 21 CFR 812.28.
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.