FDA Says Early Clinical Research of Medical Devices Coming Back to U.S.


Posted December 21, 2017

More than double the number of investigational device exemptions (IDEs) were submitted in 2017 compared to 2014, a sign that critical clinical research of innovative new medical devices is returning to the United States, according to the Food and Drug Administration (FDA). The agency credits this increase from 26 to 57 submissions to the success of its Early Feasibility Studies (EFS) Program.

“Ten years ago, when medical device manufacturers wanted to gain early clinical experience with their new devices, they often went overseas to conduct first-in-human or small clinical studies,” three members of the FDA’s Center for Devices and Radiological Health (CDRH) wrote in a Dec. 12 blog post. “However, going overseas delayed access to potentially beneficial devices for American physicians and patients.”

The EFS Program, which was finalized in 2013, promotes collaboration, regulatory flexibility, and consideration of benefit-risk principles, according to the post by Maureen L. Dreher, a research biomedical engineer; Andrew Farb, a medical officer in the Division of Cardiovascular Devices; and Owen Faris, director of the clinical trials program.

Components of the EFS Program include:

  • Opportunities for interactive review
  • Assistance in submission preparation from an EFS Program representative
  • Potential need for less nonclinical data to support study initiation relative to the data needed for larger clinical studies based on use of clinical mitigation strategies
  • New mechanisms for timely device and clinical protocol modifications

“The program represents a critical component of CDRH’s larger efforts to streamline the clinical trial initiative, to increase access for patients in the U.S. to high-quality, safe, and effective medical devices as quickly as possible,” Dreher, Farb, and Faris wrote.

The EFS Program has had a “direct and positive impact on all medical device developers” but has been especially beneficial for small companies, according to the FDA. One example highlighted in the blog post was Enspire DBS, a startup that used the EFS Program to begin a first-in-human study of its deep brain stimulation technology in combination with physical rehabilitation to restore function in stroke patients.

“The FDA was engaged and quite interested in working with us to find a mutually acceptable way to move forward with our early feasibility study,” representatives of Enspire DBS said. “We were happy with the interactive review and having an approved IDE significantly helped the company in securing funding.”

More information about the program can be found on the FDA’s new EFS Program website.