Exploring FDA Investigational Device Exemptions

Law360, New York (December 6, 2011, 3:01 PM EST) -- On Nov. 10, 2011, the U.S. Food and Drug Administration issued two draft guidance documents: Investigational Device Exemptions for Early Feasibility Medical Device Studies, Including Certain First-in-Human Studies[1], and FDA Decisions for Investigational Device Exemption Clinical Investigations.[2]

The agency also announced a small pilot program for implementation of the early feasibility study IDE draft guidance.[3] Comments on the draft guidance documents must be submitted by Feb. 8, 2012.[4]

The FDA will begin accepting applications for the pilot program on Dec. 12, 2011.

Early Feasibility Study IDE...
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