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FDA Releases “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” Draft Guidance

Today we released the “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” draft guidance, which provides recommendations to improve the quality, consistency and transparency of data on how  medical devices perform within specific age, race, and ethnic groups.  Proper evaluation and reporting of this data can benefit patients, clinicians, researchers and regulators.

The specific objectives of this guidance are to:

  1. Encourage the collection and consideration of age, race, ethnicity and associated predictive variables (e.g., body size, biomarkers, bone density, etc.) during the study design stage;
  2. Outline recommended analyses of study subgroup data, with a framework for considering demographic data when interpreting overall study outcomes; and
  3. Specify the FDA’s expectations for reporting age, race, and ethnicity-specific information in summaries and labeling for approved or cleared medical devices.

This draft guidance is not for implementation until final.  When finalized, this guidance will extend the policy set forth in the FDA’s Evaluation of Sex-Specific Data in Medical Device Clinical Studies guidance document.  The FDA intends to integrate the final contents of both guidance documents into one final guidance document.

We welcome your comments regarding this draft guidance.  The comment period will be open for 90 days in the Federal Registerunder docket number FDA-2016-D-0734 starting June 20, 2016.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041301-796-7100 or dice@fda.hhs.gov

Food and Drug Administration
Center for Devices and Radiological Health