New Draft Guidance for Medical Device Clinical Studies

FDA’s draft guidance “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies”  is now available on display in the Federal Register. 

This draft guidance contains specific recommendations to improve the design, conduct, and reporting of clinical trials to achieve better quality, consistency and transparency of data regarding the performance of medical devices within specific age, race, and ethnic groups. 

The specific objectives of this guidance are 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 analyses of study subgroup data, with a framework for considering demographic data when interpreting overall study outcomes

• Specify the FDA’s expectations for reporting age, race, and ethnicity-specific information in summaries and labeling for approved or cleared medical devices

FDA has opened a docket for comment for 90 days from the date of publication. The docket number is FDA-2016-D-0734.

View Federal Register Notice