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

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.

When FDA published a draft guidance in 2015 on how researchers can extrapolate adult clinical trial data to support PMAs and humanitarian device exemptions for pediatric medical devices, industry trade groups such as AdvaMed argued the guidance should also cover data supporting 510(k) submissions. (See Also see "510(k)s Should Benefit From Adult-To-Peds Extrapolation Too, AdvaMed Says" - Medtech Insight, 3 August, 2015..)

The agency declined to go that far, but in a

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