Early Feasibility Studies (EFS) Program
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An Early Feasibility Studies (EFS) Program is a limited clinical investigation program that enrolls only a few subjects to evaluate the initial clinical safety of a medical device in an early phase of development.
- AKA: Early Feasibility Studies (EFS) Clinical Study.
- Example(s):
- Counter-Example(s):
- See: Medical Device Development Clinical Trial, Preclinical Trial, Microdosing Clinical Trial, Approved Drug, Pharmaceutical Industry, Clinical Trial, Premarket Notification, Food And Drug Administration, Food, Drug, And Cosmetic Act, Premarket Approval, Marketing, Institutional Review Board.
References
2022
- (FDA, 2022) ⇒ https://www.fda.gov/medical-devices/investigational-device-exemption-ide/early-feasibility-studies-efs-program Retrieved:2022-1-22.
- QUOTE: An early feasibility study (EFS) is a limited clinical investigation of a device early in development. It typically:
- enrolls a small number of subjects;
- is used to evaluate the device design concept with respect to initial clinical safety and device functionality;
- and may guide device modifications.
- QUOTE: An early feasibility study (EFS) is a limited clinical investigation of a device early in development. It typically:
- CDRH's EFS Program facilitates the conduct of early feasibility studies in the United States to increase access for patients to potentially beneficial technologies and to support device innovation. EFS concepts are described in the FDA guidance document, Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical studies, Including Certain First in Human (FIH) Studies.
The EFS Program provides a mechanism for innovators to work directly with, sponsors, FDA review teams, and clinicians to work together early so they can increase the efficiency of their device development. Early clinical experience obtained from an EFS can provide insights for sponsors and FDA review teams into device proof of concept, patient characteristics that may impact performance, operator technique refinements, device safety, necessary device modifications, and human factors.
- CDRH's EFS Program facilitates the conduct of early feasibility studies in the United States to increase access for patients to potentially beneficial technologies and to support device innovation. EFS concepts are described in the FDA guidance document, Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical studies, Including Certain First in Human (FIH) Studies.