The Food and Drug Administration (FDA) issued a draft guidance on August 15 that sets forth the agency’s recommendations regarding the design of pivotal clinical investigations of medical devices. These recommendations are intended to help manufacturers and researchers design clinical investigations that satisfy premarket clinical data requirements. FDA’s press release regarding this draft guidance points out that its issuance is one of the 25 action items in the Agency’s “Plan of Action for Implementation of 510(k) and Science Recommendations” (2011 Plan of Action). The deadline for submitting public comments on the draft guidance is November 14, 2011.

Three Stages of Medical Device Studies. In this draft guidance, FDA continues to divide the clinical development of medical devices into the following three stages: (1) the exploratory stage; (2) the pivotal stage; and (3) the postmarket stage. FDA explains that the exploratory stage includes first-in-human studies and feasibility/pilot studies, which the Agency defines as preliminary clinical studies to see if larger pivotal studies are practical and to refine the study protocols for the pivotal studies. In addition, FDA defines a medical device pivotal study as “a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use.”

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