The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.'' The purpose of this document is to outline FDA's recommendations and expectations for the evaluation and reporting of 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 regarding the performance of medical devices within specific age, race, and ethnic groups.
Document
Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical D...
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82 FR 42819
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“Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (September 12, 2017), https://thefederalregister.org/documents/2017-19259/evaluation-and-reporting-of-age-race-and-ethnicity-data-in-medical-device-clinical-studies-guidance-for-industry-and-foo.