Level of evidence

FDA uses this idea when it weighs how far a body of studies can be trusted. Study design, bias, sample size and consistency between studies all raise or lower the level of evidence. It should not be confused with the EU MDR term 'level of clinical evidence', which describes how much evidence a device needs.

The collective level of confidence about the validity of estimates of benefits and harms for any given intervention or diagnostic test.

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