Skip to main content
FDA issues final guidance on subgroup data analysis, reporting in studies

A guidance offering recommendations and expectations on patient enrollment, reporting and evaluation of age-, race- and ethnicity-specific data in clinical studies of medical devices was finalized by the FDA. The document aims to promote the gathering and consideration of subgroups during a study's design stage, offer recommendations for reporting subgroup data in labeling and summaries for approved devices, and outline recommended subgroup data analyses.

Full Story: