Reminder: Join Us Tomorrow for a Webinar on the Final Guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations

On Wednesday, October 16, 2019 from 12:00 p.m. to 1:30 p.m. EST, the U.S. Food and Drug Administration (FDA) will hold a webinar to provide additional information on this final guidance and provide participants an opportunity to have questions answered by FDA experts on this topic.   On August 30, 2019, the FDA issued the Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications and Humanitarian Device Exemptions final guidance. This final 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.

View Webinar Details Questions? If you have questions about this final guidance, contact the Division of Industry and Consumer Education.