eCopy Program for Medical Device Submissions

An electronic copy (eCopy) is an electronic version of your medical device submission stored on a compact disc (CD), digital video disc (DVD), or a flash drive. Including an eCopy with your submission has been required since January 1, 2013. A submission with an eCopy that does not meet the technical standards outlined in the eCopy guidance will be placed on eCopy hold until a valid eCopy is received.

On the outer packaging of the submission (e.g., the FedEx label), identify the contents as "Initial IDE Application," "IDE Supplement," "Waiver," etc.   The same identification should appear in the “RE:” section of the cover letter.

Send the initial IDE application 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

Keep a copy of the courier Airbill.  Track the shipment on the courier website for confirmation of delivery.

File a PDF copy of the delivery confirmation with the PDF copy of the signed submission.

FDA will reply to the submission with an acknowledgement letter containing:

• the date of receipt of the IDE application
• the IDE number assigned to your application
• the name of the project manager to address in future submissions under the IDE

An IDE application is considered approved 30 days after it has been received, unless FDA informs the sponsor otherwise. An IDE may be approved, approved with conditions, or disapproved. It is advised that you obtain written confirmation (email or fax) that the FDA review has been completed and that the Study May Proceed. Please upload FDA Study May Proceed confirmation in iRIS under other study documents. In cases of disapproval, a sponsor has the opportunity to respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16.