Open-label study

Open-label designs are common for devices because the treatment is often visible. The risk of biased assessment is managed with objective endpoints, independent assessors or blinded core laboratories.

A clinical study in which the participant, health care professional, and others know which intervention or diagnostic test under study is being given (see also Non-Blinded Study).

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