Podcast: Shuren – New Uncertainty Draft Guidance Looks Beyond p-Values

After years of talking about how to tackle uncertainty of benefit/risk in devices under review, US FDA has released a guidance on the issue. Medtech Insight caught up with FDA device center director Jeff Shuren at a meeting in Washington, DC, to talk about the guidance and what he hopes will come of it.

Jeff Shuren
CDRH Director Jeff Shuren

On Sept. 5, US FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren announced the release of a new draft guidance to clarify how the agency intends to evaluate devices based on varying levels of uncertainty in the risk and benefit of the device. Medtech Insight sat down with Shuren following the Medical Device Innovation Consortium (MDIC) Annual Public Forum, where the document was announced, to chat about what he hopes will come of the guidance.

Listen to our interview in the

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