Clinical Research - Devices

A General Overview of Medical Product Clinical Investigations

Before medical devices become available to the public, clinical studies must be conducted to ensure their safety and efficacy. These studies, also known as trials, involve human participants. There are two stages for medical device clinical research conducted in humans that occur before marketing: Pilot/Early Feasibility studies and Pivotal studies. The selection of the appropriate study type depends on such factors as the stage of development, the type of marketing application, as well as the complexity of the product and the risks they pose to consumers.

Considerations for Medical Devices Clinical Trials

• Most clinical studies primarily support Premarket Approval (PMA); only a small percentage of 510(k) applications require clinical data.
  
• Clinical evaluation of new devices, modifications or new uses of legally marketed devices require investigational use, which, unless exempt, requires the submission of an Investigational Device Exemption (IDE). Having an IDE in place allows legal shipment of devices for investigation purposes.
• The Early Feasibility Studies (EFS) Program applies to devices subject to Premarket Approval (PMA), Premarket Notification [510(k)], De Novo classification, or Humanitarian Device Exemption. Eligible devices for EFS include those previously used under the Expanded Access pathway, used outside of the United States, or marketed devices for new indications.
• The pivotal stage (large-scale studies) gathers information to evaluate a device's safety and effectiveness for its intended use.

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