FDA Issues Two Draft Guidance Documents Related to Investigational Device Exemptions: Agency Also Announces Pilot Program for IDEs for Early Feasibility Studies


On November 10, 2011, the Food and Drug Administration (FDA or the Agency) issued two draft guidance documents: Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Studies, Including Certain First in Human (FIH) Studies, and FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations. The Agency also announced a small pilot program for implementation of the early feasibility study IDE draft guidance. Comments on the draft guidance documents must be submitted by February 8, 2012. FDA will begin accepting applications for the pilot program on December 12, 2011.

Early Feasibility Study IDE Draft Guidance

The early feasibility study draft guidance distinguishes early feasibility studies from traditional feasibility studies and pivotal studies. An early feasibility study is conducted using a medical device that is still in an early stage of development to generate data regarding the device’s design concept with respect to basic safety and device functionality. On the other hand, a traditional feasibility study is usually conducted using a near-final or final device to obtain preliminary safety and effectiveness information.v Both types of feasibility studies differ from a pivotal study, which is intended to collect definitive evidence of safety and efficacy sufficient to support a marketing application.

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