> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guidance on Age, Race, Ethnicity in Device Trials
- URL: https://www.fdaweb.com/guidance-on-age-race-ethnicity-in-device-trials/
- Published: 2016-06-17T12:00:00.000Z
- Updated: 2026-09-14T21:10:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135976

FDA has released a draft guidance on “[Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwNjE3LjYwNDI3OTYxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDYxNy42MDQyNzk2MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NzQ1MTY1JmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ0YXJnZXRpZD0mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&100&&&http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM507278.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)” that 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 agency says. The document aims to:

- 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.
- Outline recommended study subgroup data analyses, with a framework for considering demographic data when interpreting overall study outcomes.
- Specify the agency’s expectations for reporting age, race, and ethnicity-specific information in summaries and labeling for approved or cleared medical devices.

FDA says that when finalized, the guidance will extend the policy set forth in the FDA’s [Evaluation of Sex-Specific Data in Medical Device Clinical Studies](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwNjE3LjYwNDI3OTYxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDYxNy42MDQyNzk2MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NzQ1MTY1JmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ0YXJnZXRpZD0mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&101&&&http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm283707.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) guidance document. It intends to integrate the final contents of both guidance documents into one final guidance.

Comments on the draft guidance are encouraged for 90 days (see [*Federal Register*](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbXNpZD0mYXVpZD0mbWFpbGluZ2lkPTIwMTYwNjE3LjYwNDI3OTYxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE2MDYxNy42MDQyNzk2MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NzQ1MTY1JmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ0YXJnZXRpZD0mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&102&&&https://federalregister.gov/a/2016-14461?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)) under docket number FDA-2016-D-0734 starting June 20, 2016.