IDE Process: Receive the IDE approval
Where to mail?
Mail three copies of the entire package to:
Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
Approvals and Disapprovals
Upon the receipt of IDE, the FDA issues a letter stating the IDE number and the start-of-the-clock date. As opposed to INDs, IDEs are actually approved or dissaproved. The decision is made within 30 days upon receiving the IDE application.
In 2011 the FDA issued a Guidance on CDRH process for Approval and Disapproval of IDEs. The new Guidance provides provide for three FDA actions on IDE applications:
- Approval with Conditions
If the IDE disapproved, the FDA will send a letter detailing the deficiencies that need to be addressed. The sponsor-investigators compiles the answers to the FDA concerns and send the answers back referencing the initial IDE number.