Guidance on Age, Race Data in Device Clinical Studies

FDA has issued a final guidance on “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies” that provides recommendations to improve data quality, consistency and transparency on how medical devices perform within specific age, race, and ethnic groups. “In general,”  the guidance says, “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... FDA recognizes the practical challenges in achieving the appropriate enrollment of diverse populations. This guidance includes recommendations to overcome barriers to enrollment in order to balance these recommendations with least burdensome principles.”