1. Prepare three copies of the submission, including the cover letter (the signed original and two photocopies):
- Three-hole punched paper
- Left-hand margin of 1.5″ to allow for binding into report covers
- Submit in ACCO-like report covers (side bound, made of cover stock). Label each report cover with a typed 2” x 4” shipping label:
2.Retain a .PDF copy of the signed submission for your records.
3. On the outer packaging of the submission (e.g., the FedEx label), identify the contents: “Initial IDE Application,” “IDE Supplement,” “Waiver,” etc. The same identification should appear in the “RE:” section of the cover letter.
4. 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
5. Keep a copy of the courier Airbill. Track the shipment on the courier website for confirmation of delivery.
6. File a .PDF copy of the delivery confirmation with the .PDF copy of the signed submission.
7. 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. 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