FDA Takes Steps To Hike Age, Race, Ethnic Subgroups In Device Trials

FDA released draft guidance outlining its expectations and recommendations for the evaluation and reporting of age, race and ethnicity data in medical device clinical studies. The move comes as the agency prepares to launch a campaign to encourage members of minority groups to take part in clinical trials. FDA also plans to work with stakeholder groups to develop multi-language resources and use social media in an effort to diversify clinical trials. The agency has been under pressure from lawmakers and...