An early feasibility study (EFS) 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 to an IDE, with the FDA targeting approval in the first 30-day review cycle. EFS is not the same as first-in-human: FIH marks first clinical use anywhere, while EFS is the FDA's mechanism for early, limited, iterative evaluation.
Program figures (60 EFS IDEs/year, 4,000+ participants) as reported in the FDA EFS 10-year retrospective (Endovascular Today, May 2026). General information, not regulatory advice.
An EFS is a limited clinical study of a device early in development, typically enrolling a small number of subjects, to assess initial clinical safety and device functionality. Devices in an EFS do not need a finalized design, and clinical experience may inform device modifications before the traditional feasibility and pivotal stages. EFS studies may support devices headed for PMA, 510(k), De Novo, or HDE pathways. EFS is an FDA program; first-in-human is a developmental milestone, and the two are not synonymous. Source: FDA Early Feasibility Study Program.
Program launched 2014 (final guidance October 2013). Roughly 60 EFS IDEs approved per year since FY2017. 4,000+ participants enrolled across EFS studies since tracking began. The FDA's target is EFS IDE approval within the first 30-day review cycle. Source: EFS 10-year retrospective (Endovascular Today, May 2026).
1. Contact the appropriate EFS program representative to discuss whether your device and stage fit the program. 2. Submit a Pre-Submission describing the device, clinical context, and EFS rationale. 3. Align with the FDA on risk analysis, nonclinical testing, and clinical risk-mitigation measures. 4. Submit the IDE incorporating everything agreed in the Pre-Sub. Source: FDA EFS program page.
Devices early in development; sponsors who need clinical safety or device-functionality data that nonclinical testing alone cannot provide; teams that expect clinical experience to change the device; sponsors ready to engage the FDA early through the EFS representative and a Pre-Sub. Source: FDA EFS program page.
The FDA is shaping "EFS 2.0," recognizing the benefit of multigeography and global studies rather than insisting every early study run on US soil. Geography selection should weigh investigator access, infrastructure, EFS/FIH experience, recruitment and follow-up, insurance, cost, and data acceptance. Source: EFS 10-year retrospective (Endovascular Today, May 2026).
bioaccess has no US hospital site network. In the US it offers FDA strategy and Pre-Submission/EFS-IDE planning from Miami, and its affiliated site Amavita Research in Miami participates in cardiovascular studies when the device and study fit. Its proven execution footprint is first-in-human and early feasibility studies across 19 Latin American and Caribbean countries.
An early feasibility study (EFS) is a limited clinical study of a medical device early in development, typically enrolling a small number of subjects. Per the FDA's EFS program page, it assesses initial clinical safety and device functionality, the device design does not need to be finalized, and clinical experience from the study may inform device modifications before the traditional feasibility and pivotal stages. EFS studies may support devices headed for PMA, 510(k), De Novo, or HDE pathways.
The FDA sets no fixed enrollment number for an EFS. An EFS typically enrolls a small number of subjects, and the cohort is sized to the clinical questions the study needs to answer: enough to assess initial safety and device functionality, not powered to demonstrate effectiveness. The appropriate size is aligned with the FDA through the Pre-Submission and IDE process.
Yes. Devices in an EFS do not need to have a finalized design, and the FDA's EFS program page states that clinical experience from the study may inform device modifications before the traditional feasibility and pivotal stages. Iteration is part of the program's design: the EFS is a learning study, and what it teaches is meant to sharpen the device for the later, more expensive stages.
First-in-human describes a developmental milestone: the first time a device is used in people, wherever that happens. An EFS describes an FDA program and regulatory mechanism for studying a device early in development in a limited, iterative way. The two often overlap, but they are not synonymous. A first-in-human study can also happen outside the EFS program, including outside the United States.
The program is aimed at medical devices early in development whose sponsors need initial clinical safety or device-functionality data before a traditional feasibility or pivotal study. There is no published eligibility checklist: the FDA asks sponsors to discuss fit with the appropriate EFS program representative first, then align on the plan through a Pre-Submission. That early conversation is the first step in the FDA's outlined process.
The FDA's stated target is to approve EFS IDEs within the first 30-day review cycle, and the agency reports striving to meet it, according to the program's 10-year retrospective. Actual timelines depend on the quality of the Pre-Sub alignment: most delays trace back to unresolved questions about testing expectations or risk mitigation, not to the review clock itself.
EFS data may support devices headed for PMA, 510(k), De Novo, or HDE pathways, according to the FDA's EFS program page. The EFS itself is conducted under an IDE; the data it generates feed the traditional feasibility and pivotal stages of the chosen pathway.
The EFS is an FDA program conducted under an IDE, and EFS IDEs are generally U.S.-based studies under FDA oversight. But the FDA's 10-year retrospective recognizes the value of multigeography and global studies rather than insisting every early study run in the U.S. Many sponsors run first-in-human outside the United States, for example in Latin America, and bring those data into the U.S. program when the study is engineered from day one under 21 CFR 812.28: ISO 14155 conduct, independent ethics review, and data the FDA can validate.
Related: FDA EFS program guide · US vs Latin America first-in-human · Early feasibility studies in Latin America · FDA acceptance of OUS data · First-in-human CRO · US execution · Pre-Sub for an early feasibility study