CDRH to Update IDE, EUA Electronic Submissions System

CDRH is updating its system for IDE and emergency use authorization (EUA) submissions, allowing devicemakers to track multiple studies under one IDE submission number beginning Aug. 18. After the original submission number is received, subsequent submissions will be assigned to the appropriate study as the FDA tracks milestones in development, IDE approval and study initiation and completion, according to information posted on the center’s website.
Devices & Diagnostics Letter