The final guidance outlines FDA’s recommendations and expectations for patient enrollment, data analysis, and reporting of age, race and ethnicity data in medical device clinical studies.

The agency said the specific objectives of the 36-page final guidance, first drafted in June 2016, are to:

(1) encourage the collection and consideration of age, race, ethnicity and associated covariates (e.g., body size, biomarkers and bone density) during a study’s design stage;

(2) outline recommended analyses of study subgroup data with a framework for considering demographic data when interpreting overall study outcomes;

(3) specify recommendations for reporting age, race and ethnicity-specific information in summaries and labeling for approved or cleared devices.

FDA says it believes these recommendations will help improve the quality, consistency and transparency of data regarding the performance of devices within specific age, race and ethnic groups as well as encourage appropriate enrollment of diverse populations.

In terms of revisions from the draft to the final, the agency said they were made "as appropriate in response to the comments" to the draft guidance.

Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies