Upcoming Tracking Improvements for Investigational Device Exemption (IDE) and Emergency Use Authorization (EUA) Submissions
If you have or will be submitting an IDE application or an EUA submission to CDRH, this information is relevant to you.
This email updates information communicated in a July 29, 2013 email from the Food and Drug Administration (FDA) regarding upcoming changes in the system used by the Center for Devices and Radiological Health (CDRH) to track Investigational Device Exemption (IDE) and Emergency Use Authorization (EUA) submissions. These changes are intended to facilitate better tracking of milestones in clinical trial development, IDE approval, study initiation, and study completion, and will take effect on August 18, 2013.
The FDA has created a webpage, Upcoming IDE Tracking Improvements , with detailed information on the changes and how they will impact submitters. This webpage has been recently updated to:
- Clarify that these changes will impact all IDE and EUA submitters;
- Explain that these changes will not change the 30-day review period for IDE submissions and will not impact your ability to submit an IDE or EUA submission for review; and
- Clarify that the eCopy requirements are not changing and there are no new IT requirements for 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