Clinical studies for new medical devices are expensive to conduct and, if not designed efficiently or with sufficient scientific rigor, can add years to the product development life cycle. In the United States, since the implementation of the 1976 Medical Device Regulations, medical device companies have been working with FDA to find innovative and effective methods to bring new devices to the market. The randomized, controlled clinical trial is the gold standard; however this gold standard study design has not always been required to prove safety and effectiveness of medical devices. This paper explores the Randomized Withdrawal Study Design as a novel trial design for regulated medical device studies. A mock-up trial is described and the advantages and disadvantages of the design are analyzed. The randomized withdrawal trial has been successfully implemented in the pharmaceutical industry. In this design, all patients...

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