Feasibility study

Feasibility data guide the design of the pivotal study and the device itself. They are usually too limited to support a marketing application on their own.

A preliminary clinical study to see, for example, if a pivotal study is practical or to refine the study protocol for the pivotal study. A feasibility study is sometimes also called a pilot study.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary