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September 12, 2017

FDA Issues Guidance on Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical/Dental Device Clinical Studies

The United States Food and Drug Administration (FDA) has issued guidance on evaluation and reporting of age-, race-, and ethnicity-specific data in medical/dental device clinical studies.  The primary intent of the FDA guidance is to improve the quality, consistency, and transparency of data regarding the performance of medical/dental devices within specific age, racial, and ethnic groups.  Proper evaluation and reporting of this data can benefit patients, clinicians, researchers, regulators, and others.  Additionally, the FDA notes that it is important that clinical trials include diverse populations that reflect the intended device use population.  In general, to achieve an unbiased estimate of treatment effect in the general population, device makers should develop a strategy to enroll diverse populations, including representative proportions of relevant age, racial, and ethnic subgroups, which are consistent with the intended use population of the device.  To read the FDA guidance on evaluation and reporting of age-, race-, and ethnicity-specific data in medical/dental device clinical studies, use the link below.

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM507278.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

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