Active control investigation (active treatment control investigation)

Comparing against an established treatment answers the question that clinicians and payers usually ask, which is whether the new device does as well or better than what is used today. The choice of control drives the statistical design, for example whether the study aims for non-inferiority or superiority.

A study that uses an intervention whose effectiveness has been previously established. In a device investigation, the active control could be a device (drug or biological product) approved or cleared for that indication or a surgical procedure.

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