Improving diversity, equity, and inclusion (DEI) has long been a goal in clinical trials, in order to ensure that research findings apply to the general US population, among other key benefits. Government agencies related to healthcare have made DEI a priority, with the FDA announcing draft guidance for diversity and inclusion in clinical trials in April 2022. The guidance outlines how the makers of drugs and medical devices, including diagnostic tests, can develop a “Race and Ethnicity Diversity Plan” to ensure better representation of historically underrepresented groups in clinical trials of their products. The requirement to include such a plan for most US clinical trials was made law through legislation passed at the end of 2022. However, developing DEI plans will likely present device makers with a variety of challenges. Rachel Rangel, AuD, a clinical trial specialist at Curavit Clinical Research, discusses IDEA, a new toolkit the company launched in June 2023 to help drug and device makers meet federal diversity and inclusion requirements for clinical trials.