Pre-submission (Pre-Sub)

Pre-Subs carry no user fee and are widely used to agree on testing, clinical study design or the regulatory pathway before money is spent. FDA's feedback is not an approval, but FDA intends to stand by it unless the facts or the science change.

A Pre-Sub includes a formal written request from a submitter for feedback from FDA that is provided in the form of a formal written response or, if the submitter chooses, formal written feedback followed by a meeting.

FDA guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (May 2025), Section II.A, Pre-Submissions (Pre-Subs)