Jun 22, 2015

In an effort to boost predictability and transparency of its Investigational Device Exemption (IDE) review process, the US Food and Drug Administration has published new guidance explaining key issues the agency uses to assess benefits and risks of IDE submissions for clinical investigations of Class III and some Class II medical devices.

The guidance explains how FDA reviewers apply risk-benefit considerations and frameworks to their IDE determinations, and how risk-benefit assessments play a different role in reviewing IDE applications than for Premarket Approval (PMA) and 510(k) premarket notification reviews.

Among the guidance’s components most pertinent to IDE applicants are FDA recommendations that clinical study sponsors include summaries of benefit-risk assessment issues in their submissions to the agency. Specifically, IDE applicants’ summaries should include the following six considerations:

  • Context of proposed investigation: which disease is being targeted, how does the device under investigation treat that disease, and what are the investigation’s objective and design?
  • Assessment of proposed investigation’s risks: What are the key risks involved in the investigation—risk characterization, control measures and residual risk?
  • Assessment of proposed investigation’s benefits: What are the investigation’s key benefits for study subjects and/or expanding clinical knowledge?
  • Patient preference information: What patient preference information, if any, exists?
  • Assessment of uncertainty: Which aspects of the proposed investigation and of available clinical evidence create the most uncertainty, and why is that level of uncertainty acceptable for the proposed investigation?
  • Conclusions: How do the issues identified in this summary justify granting the IDE request and conducting the investigation?

By including this information in their IDE applications, clinical investigation sponsors and/or medical device manufacturers would directly address many key questions FDA reviewers have when examining submissions, potentially speeding up IDE decisions and avoiding hold-ups.

The FDA is accepting comments on the new IDE guidance through mid-September 2015.


  • Stewart Eisenhart