This document, issued on 7 November 2013, is intended to provide guidance to those involved in designing clinical studies intended to support pre-market submissions for medical devices and FDA staff who review those submissions. Although the Agency has articulated policies related to design of studies intended to support specific device types, and a general policy of tailoring the evidentiary burden to the regulatory requirement, the Agency has not attempted to describe the different clinical study designs that may be appropriate to support a device pre-market submission, or to define how a sponsor should decide which pivotal clinical study design should be used to support a submission for a particular device.  This guidance document describes different study design principles relevant to the development of medical device clinical studies that can be used to fulfill pre-market clinical data requirements.  This guidance is not intended to provide a comprehensive tutorial on the best clinical and statistical practices for investigational medical device studies. 

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Medical devices can undergo three general stages of clinical development. These stages may be extremely dependent on each other and doing a thorough evaluation in one stage can make the next stage much more straightforward. To begin, medical devices may undergo an exploratory clinical stage.  In this stage, the limitations and advantages of the medical device are evaluated.  This stage includes first-in-human studies and feasibility studies.  The next stage, the pivotal stage, is used to develop the information necessary to evaluate the safety and effectiveness of the device for the identified intended use. It usually consists of one or more pivotal studies.  Finally, devices undergo a post-market stage which can include an additional study or studies for better understanding of device safety, such as rare adverse events and long-term effectiveness.  This guidance provides information on design issues related to pivotal clinical investigations and does not address the other stages in any detail.

 

A medical device pivotal study is a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use.  Evidence from one or more pivotal clinical studies generally serves as the primary basis for the determination of reasonable assurance of safety and effectiveness of the medical device of a pre-market approval application (PMA) and FDA’s overall benefit-risk determination.  In some cases, a PMA may include multiple studies designed to answer different scientific questions.

 

The focus of this guidance is providing recommendations to sponsors on how to design clinical investigations to support a PMA.  However, sponsors who conduct clinical studies to support pre-market notification (510(k)) and de novo submissions may also rely on the principles in this guidance document.

 

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidances means that something is suggested or recommended, but not required.