What does a Pre-Sub Meeting provide to applicants?

A Pre-Submission (Pre-Sub) Meeting offers applicants a valuable opportunity to receive feedback directly from the FDA regarding their intended submission. This meeting occurs before the formal submission of a device or product and is particularly beneficial for applicants who want to clarify the agency's expectations and ensure that they are on the right track. During this meeting, applicants can discuss their proposed studies, address any specific questions they might have, and seek guidance about the appropriate regulatory pathway for their device. This interaction can help to identify potential issues early in the process and ultimately enhance the quality and success of the submission.

While discussions about manufacturing practices and consultation on pricing strategies may be relevant to the overall product development process, they are not the primary focus of a Pre-Sub Meeting. Furthermore, it is essential to understand that a Pre-Sub Meeting does not guarantee approval; it only provides guidance and feedback, which may aid applicants in preparing their submissions more effectively.