Informational meeting

Companies use it, for example, to give FDA an overview of a new technology or development program before a later submission. Because FDA gives no feedback, it is not a substitute for a Pre-Submission.

An Informational Meeting is a request to share information with FDA without the expectation of feedback.

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