Pivotal study

The pivotal study is what FDA reviews most closely in a PMA or De Novo, and sometimes in a 510(k). Its endpoints, control and statistical plan are best agreed with FDA early, often through a Pre-Submission.

A definitive study during which evidence is gathered to support the safety and effectiveness evaluation of the medical device for its intended use.

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