Regulatory Approval

Clinical development of a new medical device comprises exploratory and pivotal clinical studies in addition to pre-clinical work that includes bench and animal studies.

Stage 1: Investigational Device Exemption (IDE)

An investigational device exemption (IDE) must be approved prior to beginning any clinical studies, including using an investigational device to collect safety and efficacy data to support an application for marketing a device.

There are two types of traditional IDE studies:

  • Feasibility/Pilot Studies (Early or Traditional)
  • Pivotal Study

Stage 2: Pilot/Feasibility Clinical Trials

Clinical pilot studies are performed in the early phase of medical device development. These studies are conducted to:

  • Evaluate the device design concept
  • Establish performance characteristics
  • Establish preliminary safety and effectiveness prior to beginning a pivotal trial
  • Explore eligibility criteria
  • Aid in the design of the pivotal clinical study

Stage 3: Pivotal Clinical Studies

Pivotal studies are conducted to determine the safety and effectiveness of a device for a defined intended use, in a certain patient population and in a statistically justified number of subjects. It usually consists of one or more studies.

There are two main types of pivotal clinical studies that can be conducted for diagnostic medical devices:

  • Clinical outcome studies
  • Diagnostic clinical performance studies

When designing a clinical study of a diagnostic device, the following characteristics and features should be addressed in the clinical study design since they will influence how the device is evaluated by the FDA:

  1. How and why the device works, for example, the scientific principles underlying the device function and mechanism of action
  2. Required level of skill and training for the user
  3. Expected learning curve for the user
  4. Consideration of human factors, such as the user interface, the user’s expectations of the device and the user’s abilities and training

Stage 4: Medical Device Classification and Application Process

In the United States, medical devices are classified into Class I, II, and III.

Depending upon the classification of your device, there are two regulatory routes to market:

  • Premarket Notification (510K)
  • Premarket Approval (PMA)