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FDA issues new draft guidance documents clarifying how benefit-risk determinations are made, considerations for designing pivotal clinical studies

15 September 2011

Medical Device Alert

On Monday, 15 August  2011, the Food and Drug Administration's (FDA or "the Agency") Center for Devices and Radiological Health (CDRH) issued two important draft guidance documents, one regarding the factors that the Agency will consider when making benefit-risk determinations during the premarket review process, and one discussing design considerations for pivotal studies of medical devices. Each of these guidance documents are discussed below.



Read "FDA issues new draft guidance documents clarifying how benefit-risk determinations are made, considerations for designing pivotal clinical studies"

The team

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