Placebo (sham)

Sham controls are the device version of a placebo, such as a procedure without the active treatment. They raise ethical questions, because subjects undergo procedures without an expected benefit, so the risk to them has to be justified.

A device that is thought to be ineffective. In clinical studies, experimental interventions are often compared with placebos to assess the intervention's effectiveness (see placebo control study).

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