1. Medtech Insight

Balancing Diversity and Effectiveness: Industry Feedback on FDA’s DAP Guidance

 
• By Elizabeth Orr

The medical device industry supports the FDA's draft guidance document on Diversity Action Plans but seeks flexibility and clarity, especially for international and IVD trials, and recommends using real-world data for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.

Photo illustration demonstrating competing interests balancing on a scale.
(SvetaZi /Shutterstock)

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.

The comment was one of about 140 submitted in response to June’s draft guidance document on improving enrollment of...

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