Early Feasibility Medical Device Clinical Studies

Early Feasibility Medical Device Clinical Studies

On October 1, 2013, the Food and Drug Administration (FDA) released a final guidance document, “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.”

This guidance was developed to facilitate the early clinical evaluation of medical devices in the United States under the IDE regulations, using risk mitigation strategies that appropriately protect human subjects while allowing for less preclinical data to support the IDE approval.  This program demonstrates FDA’s awareness that important new technologies should be made available to U.S. patient sooner.

The Early Feasibility Study (EFS) program is intended to be used for devices that are early in their development lifecycle for which preclinical test methods are either not available or adequate to provide information to advance the device development process.  Although EFS IDEs must comply with 21CFR812 requirements, the structure of the IDE application for EFS provides for the use of risk mitigation strategies rather than a complete suite of engineering testing.  The use of the device in a small patient population with appropriate risk mitigation strategies allows you to learn more about the clinical safety of your device, operator technique challenges, device performance in its intended purpose, patient characteristics that may impact your device performance, and the appropriate therapeutic parameters associated with your device.

In addition to the reduced burden of preclinical testing, the EFS program provides for more flexibility during the IDE review process.  This includes the increased use of 5-day notifications that don’t require FDA pre-approval for minor device modifications, contingent FDA approvals (i.e., approval of anticipated device changes obtained contingent on completion of agreed-upon test plan), and an interactive review process.

In January 2015, the FDA held a webinar to discuss the medical device clinical trials program at CDRH.  During this webinar, Owen Faris Ph.D., Acting Clinical Trials Director for CDRH, spent a significant amount of time discussing the Early Feasibility Study program and described the actions CDRH is taking to make this program successful.  EFS experts have been trained and deployed in each review division to assist Sponsors and FDA review teams, and Dr. Faris noted that FDA is cognizant of ensuring important new technologies are available to U.S. patient sooner.

How Can BBA Help You?

Boston Biomedical Associates has already helped clients successfully navigate through the EFS evaluation process and has EFS programs underway.

BBA can help you navigate through the Early Feasibility Program and propel you to market sooner by providing the following services:

  • Evaluation of your device and planned indications for use to determine if your device may be eligible for the EFS program
  • Review your preclinical test plan to ensure all appropriate critical design elements associated with patient risks have been mitigated.
  • Write pre-submission package and participate in FDA meetings to negotiate your device being part of the EFS program
  • Write your EFS Investigational Device Exemption (IDE), ensuring all FDA requirements are met.
    • Inclusive of writing the Device Evaluation Strategy to support the Report of Prior Investigations section.
  • Write your Investigational Plan per 21CFR812.25, incorporating EFS requirements for risk mitigation strategies
  • Execute your Early Feasibility Study using our experienced Clinical Operations team.

Let BBA partner with you to achieve your unique vision.

Marybeth Gamber
mgamber@boston-biomedical.com

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