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The U.S. Food and Drug Administration’s Center for Devices and Radiological Health’s new module, Incorporating Voluntary Patient Preference Information (PPI) Over the Total Product Life Cycle, Final Guidance, is now available online. This module discusses updated recommendations for industry and FDA staff for designing, collecting, and evaluating PPI in the context of benefit-risk assessments of devices.
The presentation, printable slides, and transcript are available now on CDRH Learn under “How to Study and Market Your Device,” sub-section “Cross-Cutting Premarket Policy.”
Questions?
If you have questions about this final guidance, please contact the Division of Industry and Consumer Education.
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