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FDA Declines To Add 510(k)s To Pediatric Data Guidance, But Does Address De Novos

This article was originally published in The Gray Sheet

Executive Summary

Industry has asked FDA to expand the scope of its guidance on extrapolating adult trial data to pediatric submissions to include 510(k)s. In a final guidance, FDA declined to do so, but it did expand the scope of the guidelines to include de novo applications.

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