Guidance Document on Data Reporting

"Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies" is a 36-page document, issued in 2017, that provides guidance for industry and Food & Drug Administration (FDA) staff outlining the FDA’s data-reporting expectations and recommendations for the evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and ethnic groups. Proper evaluation and reporting of this data can benefit patients, clinicians, researchers, regulators, and others.