Meta-analysis

Meta-analyses can strengthen clinical evidence, but only when the pooled studies are truly comparable in device, population and endpoints. Under 21 CFR 814, a new meta-analysis that reveals a new or greater risk counts as newly acquired information.

A statistical synthesis of the data from separate but similar (i.e., comparable) studies, leading to a quantitative summary of the pooled results.

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