Upcoming IT Improvements for IDE and EUA Submissions
On August 18, 2013, the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) will be updating the system used to process Investigational Device Exemption (IDE) and Emergency Use Authorization (EUA) submissions to facilitate better tracking of milestones in clinical trial development, IDE approval, study initiation, and study completion. These changes will impact IDE and EUA submitters because the submission structure is changing in multiple ways.
The FDA has created a web page, Upcoming IT Changes to IDE and EUA Submissions , with detailed information on the changes and how they will impact submitters.
The IDE Staff can help answer questions related to these changes at 301-796-5640.
Thank you for your continued support,
Food and Drug Administration
Center for Devices and Radiological Health