Historical control group

Historical controls can save time, but patients, practice and measurement methods may have changed since they were observed. FDA generally prefers concurrent controls and expects a justification when historical data are used.

A control group of subjects who were observed prior to the pivotal study. Data collected from this control group is used to compare the performance of the investigational device.

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