Medtech wants US guide on extrapolating clinical data to pediatric population to include 510(k)s
This article was originally published in SRA
Executive Summary
US medtech industry association AdvaMed is urging the Food and Drug Administration to expand the scope of its draft guideline on extrapolating existing clinical data to support medical device approvals for pediatric population so that it also covers pre-market notification, or 510(k), applications1.