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  5. Webinar - Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance - February 23, 2017
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Webcast

Event Title
Webinar - Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance - February 23, 2017
February 23, 2017

Webinar - Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance - February 23, 2017


Date:
February 23, 2017
Time:
February 23, 2017

     

Webinar Materials

The FDA published a final guidance clarifying key factors it considers when assessing the benefits and risks of Investigational Device Exemption (IDE) submissions for human clinical study.

The final guidance:

  • Enhances the predictability, consistency and transparency of the IDE review process;
  • Provides a common understanding between the FDA staff and clinical trials sponsors on what information informs the benefit-risk assessment of an IDE submission; and
  • Facilitates 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 guidance is a 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, with hypothetical assessments as examples.

Release of this guidance is part of the FDA’s on-going efforts to improve patient access to new devices by strengthening and streamlining clinical trials. It does not change sponsor requirements.

FDA hosted a webinar on Thursday, February 23, 2017 to help manufacturers and other interested stakeholders understand the information provided in this final guidance document.

Following a brief presentation, the FDA responded to questions.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, or by phone 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health