Is the FDA’s EFS Program Right for Your Medical Device?

Is the FDA’s EFS Program Right for Your Medical Device?

What is an Early Feasibility Study (EFS)?

The FDA created its EFS program to help increase patient access to new, innovative technologies in the United States. The program is optional, but the idea is that tools from the EFS program, like a device evaluation strategy (DES), can be used throughout product development to streamline the process.

If an EFS is not required, how do you know if you should conduct one?

Since an EFS is not required and not always needed, the FDA recommends an EFS be conducted if:

  • The device design is likely or still has potential to change
  • There is less nonclinical data available for the study
  • The purpose of the study is to give initial insights to guide device modifications
  • There is a lower understanding of device risks
  • There is a small number of patients (~10)

This means that a traditional feasibility study should be conducted when:

  • The device design is not likely to change and is final or near-final
  • Preclinical data provides information needed for device design
  • The purpose of the study is to capture preliminary S&E to help design pivotal study
  • The risks are understood
  • The number of patients is around 15-45

Things to consider

There are always exceptions to the rule. You can still request an EFS if your device design is in the final stages and is not likely to change. In this case, it is still possible that the goals of your study align with those recommended for the EFS program. You can also request an EFS if your product is already being marketed or is in a clinical study inside or outside the US if nonclinical data is not enough to support a traditional feasibility study or if the device is not being used as intended.

EFS GraphicEFS Benefits

  • Allows engagement with US physicians and sites
  • No need to extrapolate OUS medical care in US data population
  • Earlier access to US patients, novel treatments, and podium presence
  • Earlier logistics vs OUS trials
    • No/minimal translations
    • Few time-zones
    • Avoidance of long travel times
    • Shipping of investigational devices/ avoid FDA export requirements
  • Educated FDA on treatment and paves the way for future engagements

EFS Risks

  • Limited experience across all branches in the FDA as program evolves
    • CDRH leadership and management are committed
    • Continue to work to change mindsets on amount of testing needed to support EFS vs. traditional IDE

Key Takeaways

The Global trial landscape continues to shift as countries like the US accelerate innovation. The FDA’s EFS program is essentially the first step towards a clinical trial and may be right for you depending on the above criteria. Remember, there are always exceptions, so if you need more information feel free to check out the FDA’s website.

To ensure a successful performance in your EFS study and to get valuable data that expedites product development and optimizes opportunities for bringing devices to market, contact us.

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Wanda Carpinella
wcarpinella@bbacro.com

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