Division of Clinical Research

Office of the Vice President and Innovation

On October 16, 2019, the U.S. Food and Drug Administration (FDA) hosted a webinar to share information and answer questions about the final guidance, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions. This 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. This includes devices subject to premarket approval (PMA) applications, De Novo requests, and humanitarian device exemption (HDE) applications.

Webinar Materials are available here for:

Categories FDA Regulatory
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