This insight brief explains how Diversity Action Plans (DAPs) help ensure medical device clinical trials reflect the populations that will ultimately use the devices. It outlines why diversity matters for safety, effectiveness, regulatory confidence, and equitable access to innovation, particularly as FDA expectations continue to evolve. The brief details core DAP requirements, including defining underrepresented populations, setting measurable enrollment goals, and documenting strategies to achieve them. It shows how DAPs influence protocol design, eligibility criteria, and endpoint selection, as well as site selection, monitoring, and investigator engagement. The role of technology, data transparency, and real-time reporting is emphasized as critical to tracking progress and enabling cou

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