Pivotal stage

FDA's guidance describes device clinical development in stages: exploratory, pivotal and postmarket. Design changes are expected in the exploratory stage, so a device entering the pivotal stage should be in, or close to, its final form.

Clinical development stage for medical devices during which the evidence is gathered to support the evaluation of the safety and effectiveness of the medical device. The stage consists of one or more pivotal studies.

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