AdvaMed is urging FDA to expand the scope of its draft guidance
on extrapolating existing clinical data to support medical device approvals for pediatric population so that it also covers 510(k) applications.
510(k)s Should Benefit From Adult-To-Peds Extrapolation Too, AdvaMed Says
The trade group says FDA's recent draft guidance on employing adult device data to help support a pediatric indication should be expanded to include 510(k)s, rather than being limited to PMAs and HDEs.