FDA Issues New Draft Guidance Documents Outlining IDE Decision Pathways; New Policies and Pilot Program for Early Feasibility IDE Studies

On Thursday, 10 November 2011, the Food and Drug Administration (FDA or "the Agency") issued two draft guidance documents, one regarding the range of potential pathways and FDA decision-making for investigational device exemption (IDE) applications, and one discussing the Agency's approach and new policies regarding early feasibility IDE studies.

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