Exploratory stage

FDA describes device clinical development in stages: exploratory, pivotal and postmarket. In the exploratory stage the design can still change, while the pivotal stage is meant to confirm safety and effectiveness of a settled design.

A medical device clinical development stage that includes initial development, evaluation, first-in-human and other feasibility studies.

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