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Clinical Trials Resource Group

Clinical Trials Resource Group

Number5IDE 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
  •  Approval with Conditions
  •  Disapproval

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.

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