The US Food and Drug Administration’s final guidance document on Diversity Action Plans (DAPs) should carve out devices that are equally effective across demographics, trade group the Medical Device Manufacturers Association said in a recent public comment.
Balancing Diversity and Effectiveness: Industry Feedback on FDA’s DAP Guidance
The medical device industry supports the FDA's draft guidance document on Diversity Action Plans but seeks flexibility and clarity, especially for international and IVD trials, and recommends using real-world data for postmarket studies.
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