On Sept. 5, US FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren announced the release of a new draft guidance to clarify how the agency intends to evaluate devices based on varying levels of uncertainty in the risk and benefit of the device.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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