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

PUBLISHED: Sep 11, 2017
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals

The US Food and Drug Administration (FDA) has issued final guidance for industry and FDA staff outlining FDA’s 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.

The FDA believes that it is important that clinical trials include diverse populations that reflect the intended use population. In general, to achieve an unbiased estimate of treatment effect in the general population, sponsors 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. The FDA guidance includes recommendations and considerations to assist sponsors in developing such a strategy.

The specific objectives of this guidance are to:

  • Encourage the collection and consideration during the study design stage of relevant age, race, ethnicity, and associated covariates (e.g., body size, biomarkers, bone density) for devices for which safety, effectiveness (or, for humanitarian device exemptions (HDEs), probable benefit), or benefit-risk profile is expected to vary across these groups;
  • Outline recommended analyses of study subgroup data, with a framework for considering demographic data when interpreting overall study outcomes; and
  • Specify FDA’s expectations for reporting age, race, and ethnicity specific information in summaries and labeling for approved or cleared medical devices.

Follow the link below to access the FDA Guidance.

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