> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Number of Early Feasibility IDEs More Than Double
- URL: https://www.fdaweb.com/number-of-early-feasibility-ides-more-than-double/
- Published: 2017-12-12T12:00:00.000Z
- Updated: 2026-09-14T23:07:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140322

Three CDRH staffers working in the Early Feasibility Studies (EFS) program that the number of investigational device exemptions (IDE) submitted for EFS has more than doubled from 26 submissions in the first year after the EFS guidance was finalized to 57 submitted in FY 2017\. Writing in an *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2017/12/bringing-early-feasibility-studies-for-medical-devices-back-to-the-united-states/?ref=fdaweb.com), CDRH Early Feasibility Study program representative **Maureen Dreher** and two colleagues say the program provides a route for innovators, sponsors, FDA review teams, and clinicians to work together to facilitate the early clinical evaluation of medical devices under the IDE regulations. The route allows early testing of medical devices in the U.S. rather than elsewhere in the world, they say.

“An EFS is a limited clinical study on a device early in its development,” the authors write, “typically before the device design has been finalized, for a specific indication. It may be used to evaluate the device design concept with respect to initial clinical safety and device functionality. The EFS program includes enhanced opportunities for collaboration, increased regulatory flexibility, and consideration of benefit-risk principles, while maintaining appropriate patient protection measures.”

The post says that most of the EFS studies received timely FDA approval. Thus, in the last two years, 75% of the IDE submissions that are required to conduct any clinical study on an investigational device have been either approved or approved with conditions within one 30-day review cycle.

Testimonials to program success from several stakeholders are included in the post.