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# FDA Guide on Device Study Reporting of Age, Race Data
- URL: https://www.fdaweb.com/fda-guide-on-device-study-reporting-of-age-race-data/
- Published: 2017-09-12T12:00:00.000Z
- Updated: 2026-09-14T22:48:47.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139604

*Federal Register* notice: FDA has made available a guidance entitled “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.” The document outlines FDA’s recommendations and expectations for evaluating and reporting age, race, and ethnicity data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data on the performance of medical devices within specific age, race, and ethnic groups. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-09-12/pdf/2017-19259.pdf?ref=fdaweb.com).