Sponsors are encouraged to submit pre-IDE submissions to the ODE reviewing division while the sponsor is preparing a formal IDE submission whenever the sponsor requires informal FDA guidance on troublesome parts of the IDE application, for example, clinical protocol design, preclinical testing proposal, etc. Pre-IDE submissions are logged into the pre-IDE tracking system by the Document Mail Center (DMC). After the document is logged-in, the DMC will jacket the submission in a white folder, attach a tracking sheet, print an acknowledgment letter to the pre-IDE sponsor, and forward the submission and letter to the appropriate reviewing division. The division should verify that the submission belongs to their division and, after signing the acknowledgment letter and placing a copy of it in the pre-IDE, mail the letter to the sponsor.
Upon completion of the review of the pre-IDE submission, the division is responsible for issuing a response to the sponsor in a timely manner, usually within 60 days of receipt. The response may take the form of a letter or comments provided during a meeting or teleconference. If FDA’s response is provided via comments during a meeting or a telephone conference call, a memo of the meeting or conference call should be prepared. The division is responsible for ensuring that all memos, reviews, letters, etc. are included in the jacketed file copy for documentation. Upon completion of the review, the document should be returned to the DMC for filing.