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Tag: Medical Device Premarket Approvals

FDA Webinar: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

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 […]

FDA Medical Device Webinars for October 2019

The FDA’s Center for Devices and Radiological Health (CDRH) hosts webinars to help educate stakeholders on guidances and other topics related to the regulation of medical devices and radiation-emitting products. These forums provide the medical device industry and others with the chance to interact with FDA officials and have their questions answered. Webinars scheduled for […]

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