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 that these products are safe and efficacious. These studies, also called trials, involve human participants. There are two stages for medical device clinical research in humans before marketing, Pilot/Early Feasibility studies and Pivotal studies. The type of study that needs to be conducted depends on the stage of development, the type of marketing application, as well as the complexity and risks associated with the product on 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 EFS Program applies to devices subject to Premarket Approval (PMA), Premarket Notification [510(k)], De Novo classification, or Humanitarian Device Exemption. Suitable 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 assess a device's safety and effectiveness for its intended use.

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