- February 22, 2017
07:00 PM - 07:00 PM EST
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 firstname.lastname@example.org, or by phone 1-800-638-2041, or 301-796-7100.
Food and Drug Administration
Center for Devices and Radiological Health