CDRH’s Early Feasibility Study Program

1/22/18

What is an Early Feasibility Study?

  • An Early Feasibility Study (EFS) is a clinical investigation of a device early in the development phase, before the design is finalized.
  • EFS serves as an initial evaluation of the device design’s performance and clinical safety.
  • Modifications to the device can be made as a result of the early study findings, thus improving innovation, safety, and/or effectiveness.

What is the EFS Program?

  • The FDA’s Center for Devices and Radiological Health (CDRH) started the EFS Program in an effort to support innovation of new technologies and to expedite access to potentially lifesaving new devices for Americans.
  • The EFS program encourages collaboration between the FDA, sponsors, Investigators, and medical device innovators during the early clinical investigations of devices to boost efficiency of device development.
  • The EFS Program is part of FDA and CDRHs’ Strategic Priorities to reduce the time and cost burden of device clinical trials while continuing to support quality data and subject safety.
  • The EFS Program is administered under the Investigational Device Exemption (IDE) regulations, as described in the October 2013 Guidance Document, “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.”

Why was the EFS Program necessary?

  • Due to concerns over studies in the US causing an undue burden of time and resources, medical device manufacturers conducted many of their first in human device studies overseas.
  • Studies conducted outside the US caused delays in the devices being marketed in the US and reduced clinician experience with the devices prior to marketing.

Improvements expected from the EFS Program:

  • Faster approval of IDE submissions.
  • Greater familiarity with new devices among clinicians.
  • Increased early clinical studies conducted inside the United States.
  • Small device manufacturers may:
    • Benefit from a reduction in monetary and resource costs, and
    • Gain financial backing earlier due to the results from EFS.
  • Collaboration between the FDA review team and the sponsor
    • Provides access to FDA experts, and
    • Increases the success of device clinical trials.

CDRH’s EFS Program encourages innovation and streamlines the process for medical device manufacturers to provide access to high quality, safe, effective medical devices in the United States. More than double the IDE submissions in the US during the first year after the finalized Guidance Document was released suggests an initial success of the EFS Program.

- The Clinical Pathways Team

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