Medical Devices Clinical Research

In the context of medical devices, a clinical trial or a clinical investigation can be defined as any systematic investigation or study on one or more human subjects undertaken to assess the safety or performance of a medical device. Clinical trials for medical devices are predominantly conducted to identify the safety and performance of these devices in the treatment, prevention or diagnosis of disease. More than double the number of investigational device exemptions (IDEs) were submitted in 2017 compared to 2014, a sign that critical clinical research of innovative new medical devices is returning to the United States, according to the Food and Drug Administration (FDA). Medical device clinical trials are different from drug trials in that only patients with the condition which the device is designed to treat are involved. They are traditionally comprised of three different types of studies.

Exploratory or Feasibility Study:  Exploratory studies (also known as feasibility studies) are conducted in the early stages of device development. They are used to establish preliminary safety and effectiveness of the device and design the next stage of the trial, the pivotal study.

Pivotal Study: Pivotal studies are performed to demonstrate the device is safe and effective for a specific use within a defined patient population. The results of a pivotal study are used to gain regulatory approval to market the device.

Post market Study: Run either as a condition of approval to meet a business objective, post-market studies are similar to Phase IV of clinical drug trials since the goal is to better understand long-term effectiveness of the device and potential adverse events associated with the use of the device.

 

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