FDA Issues Final Guidance on Considering Uncertainty

Today, the U.S. Food and Drug Administration (FDA) issued the final guidance, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions. Updates were also made to another final benefit-risk determinations guidance to align with this final guidance—read below for more information on these changes. About the Guidance This guidance describes the FDA’s consideration of uncertainty when determining benefit-risk for certain premarket decisions on medical devices based on the totality of the valid scientific evidence. The guidance outlines a rigorous, methodical approach for the consideration of uncertainty when assessing the benefits and risks of a medical device and for determining when it may be appropriate to shift some data collection from the premarket to the postmarket phase.  Although considering the extent of uncertainty of benefits and risks is already a part of product review, this guidance makes these considerations more transparent, consistent, and objectively defined.

Read the Final Guidance Changes to Align Existing Guidance Documents The FDA also updated the guidance, “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” which describes the principal factors, including uncertainty of benefits and risks, the FDA considers when making benefit-risk determinations for certain premarket decisions. Appendices B and C of this guidance are updated with a revised Benefit-Risk Determination Worksheet that incorporates the same factors for benefit-risk determinations described in the guidance. The revised worksheet provides structure to guide and organize the benefit-risk factors and to support consistent decision-making. Webinar On October 16, 2019, the FDA will host a webinar for stakeholders interested in learning more about this final guidance.  Questions? If you have questions about this guidance, contact the Division of Industry and Consumer Education.