IDE Application- Suggested Format for IDE Submissions

In order to facilitate FDA's handling of IDE applications, the following recommendations are offered:

• Use paper with nominal dimensions of 8 1/2" by 11".
• Use at least a 1 1/2" wide left margin to allow for binding into jackets.
• Use 3-hole punched paper to allow for binding into jackets.
• If the submission exceeds 2" in thickness, separate into volumes and identify volume number.
• Clearly and prominently identify submission as original IDE application or, for additional submissions to an IDE application, clearly identify the FDA assigned document number (e.g., G960000) and the reason for the submission (e.g., amendment or supplement) and the type of submission (e.g., Response to FDA letter; Addition of New Institution, etc.).
• All copies of each submission must be identical.
• Do not combine IDEs, PMAs and 510(k)s together; they must be separate submissions.
• Unless the IDE sponsor has provided authorization in writing for another person to submit information on the sponsor's behalf, only the IDE sponsor may amend, supplement, or submit reports to the IDE.
• Sequentially number the pages, providing a detailed table of contents, and use tabs to identify each section. This will help to facilitate the review of your submission.