New US FDA guidance: Six benefit-risk factors to include in medical device IDE applications

By Stewart Eisenhart

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?


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