Early Feasibility Study (EFS) Initiative

What is an Early Feasibility Study?

An Early Feasibility Study (EFS) is a small clinical study designed to gain early insights into an innovative medical technology during the development process, before starting a larger clinical trial.  An EFS often serves as a critical step in device innovation.

Benefits of EFS:

  • Although conducting of an EFS is optional, EFS conduct facilitates direct and interactive collaboration between FDA, sponsors and innovators in the earliest product lifecycle stages.
  • First-in-World access to potentially beneficial medical devices to patients in the US.
  • Familiarize regulatory review teams and care providers with the technology earlier in the product development process, applying a learn-as-you-go approach.
  • Ability to justify doing the right testing at the right time.
  • More streamlined Clinical Testing (see details in Appendix)
    • Capturing EFS data that is relevant to the US population and therefore directly supportive of subsequent US clinical studies (e.g. Pivotal, Post-Market, etc.)
    • One IDE across US clinical studies: EFS, Traditional Feasibility and Pivotal trials. Ability to request initiating a new phase of study under the same IDE number

What is the issue?

Historically, feasibility studies have often been conducted Outside of the Unites States (OUS) due to real or perceived resource constraints/requirements (costs and time) associated with US study conduct.  When medical technology developers prioritize conducting OUS feasibility and pivotal clinical studies over US studies, the relevant technologies are (A) delayed in reaching US patients, and (B) delayed in providing clinicians with hands-on experience using the technology.

Consequences Include:

  1. The U.S. leadership role in medical technology innovation risks diminishing in prominence
  2. Delaying U.S. patient access to innovative technologies (a.k.a, the U.S. risks losing First-in-World access for patients)

What is the mission?

The FDA’s Center for Devices and Radiological Health (CDRH) established the EFS program in an effort towards achieving its strategic priority of facilitating First-in-World patient access to safe and effective new technologies of significant health importance.  Additionally supporting this priority, the Agency released its final Guidance (October 2013) titled Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.

Understanding that support during the earliest phases of medical device testing encourages medical device innovation and access for U.S. patients, MDIC, as the first public-private partnership focused on medical devices, supports this CDRH strategic priority through the Early Feasibility Study (EFS) Working Group.  MDIC is in a unique position to develop tools and best practices to support implementation and broad participation of CDRH’s EFS program via close collaboration between FDA, industry, providers and other stakeholders.

Has the EFS Program made Progress?

Significant early progress has been made:

  1. Time for EFS IDE protocol approval has substantially decreased
  2. 50% increase in the number of EFS submissions during the first nine months of 2015, compared with the same period in 2013
  3. In 2017, the most recent full year on record, Industry-sponsored EFS submissions to CDRH hit their highest level (N=57), with over 70% of those EFS submissions receiving a 1st Round approval or conditional approval.

Nonetheless there are still improvement opportunities to shorten EFS initiation activities and expedite EFS study subject enrollment.

What role does the MDIC EFS project play?

To support continued participation in the EFS program and improve the sustainability of EFS objectives, the MDIC EFS project is focusing on identifying and removing remaining barriers to EFS initiation.  Specifically, MDIC is (1) tracking EFS performance metrics, and (2) developing tools and best practices for EFS sponsors and clinical researchers alike.  In combination, these efforts are anticipated to drive overall EFS efficiency and support continuous assessment of EFS efficiency and effectiveness for US patients.

What is the Impact of MDIC EFS project?

  • Further improve timelines for EFS Administrative & Clinical Practices including: IRB review, Contracting and First Subject Enrolled.
  • Encourage more EFS-eligible technologies to be studied in the U.S.
  • Increase instances of First-in-World innovative technology access for U.S. patients.