File the IDE

The FDA now requires an electronic copy (eCopy) of the IDE submission.  An eCopy is defined as an exact duplicate of the paper submission, created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive.  An eCopy is accompanied by a paper copy of the signed cover letter and the complete paper submission.

Refer to the following guidance for specific details for an eCopy IDE submission:  “eCopy Program for Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff, December, 2012″.

There are technical standards for an eCopy submission (described in the guidance document referenced above).  If an eCopy does not meet all of the required standards, it will not pass the FDA’s eCopy loading process.  In that case the eCopy will not be accepted by the FDA.  At this time, there is no FDA tool available to pre-validate an eCopy.  However, there is a free eSubmitter-eCopies tool available at which will create an e-Copy in real-time that is consistent with the required technical standards.

For an initial submission, the IDE Sponsor-Investigator submits one full paper copy and two eCopies of the submission to the following address via overnight courier:

Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002

Keep a photocopy of the courier air bill.Keep a copy of the entire IDE submission.

The FDA responds to the initial submission of a new IDE with a letter, acknowledging receipt of the submission and assigning the IDE number.  The IDE Acknowledgement letter also provides the mailing address for all subsequent submissions to the IDE.

The FDA regulations provide for three FDA actions on IDE applications:

• Approval
• Approval with Conditions
• Disapproval

The FDA has thirty days to respond to the sponsor-investigator.  The FDA must inform the sponsor-investigator of its decision, or must notify the sponsor that the investigation may not begin, within 30 days from the date of receipt of the IDE application, or the IDE application will be deemed approved. If an IDE application is approved or approved with conditions, the sponsor may begin subject enrollment, with the maximum number of subjects and investigational centers specified in FDA’s decision letter, upon receipt of Institutional Review Board (IRB) approval.

If FDA does not have outstanding issues that must be addressed to support the study of the subject cohort under the proposed investigational plan, then the IDE will be approved without conditions.  Alternatively, if FDA has identified issues that must be addressed in a timely manner but do not preclude initiation of the clinical investigation, the IDE will be approved with conditions. In the case of approval with conditions, approval is granted and the study may be initiated immediately on the condition that, within 45 days from the date of FDA’s decision letter, the sponsor submits information addressing the issues identified in FDA’s letter. In certain instances, resolution of outstanding issues may be necessary before initiation of subject enrollment. In these instances, the IDE will be disapproved, meaning that the sponsor-investigator may not initiate enrollment in the clinical investigation until the sponsor-investigator responds to the issues identified in FDA’s letter and receives an approval or approval with conditions letter.