Announcing Draft Guidance on Factors to Consider When Making Benefit-Risk Determinations for Medical Device IDEs

Today the FDA released a draft guidance document, “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDE).”  The guidance clarifies key factors the FDA considers when assessing the benefits and risks of IDE submissions for human clinical study.

When finalized, the guidance will:

• Enhance the predictability, consistency and transparency of the IDE review process; • Provide a common understanding between the FDA staff and clinical trials sponsors on what information is critical to the benefit-risk assessment of an IDE submission; and • Facilitate the incorporation of evidence and knowledge from different domains—clinical, nonclinical and patient—to support a comprehensive, balanced decision-making approach.

Also included in the draft guidance is a proposed framework for benefit-risk assessment that we are recommending IDE sponsors provide as part of their application. The framework outlines a preferred approach for summarizing the key considerations in the benefit-risk assessment for the device. The draft guidance also provides examples of hypothetical assessments to provide additional clarity.

Release of this guidance is part of the FDA’s on-going efforts to improve patient access to new devices by strengthening and streamlining the clinical trial enterprise. It does not propose a change in sponsor requirements or how the FDA reviews IDE submissions. Rather, this guidance explains how FDA’s assessment of benefits and risks impacts the IDE decision, and proposes a common framework to facilitate better communication of this information between clinical trial sponsors and FDA staff.

We welcome and encourage your comments and suggestions regarding this draft guidance. The comment period will be open for 90 days.