Presubmission Support

A Presubmission (Q-Submission) is an opportunity to present a new device or IVD to the FDA and receive FDA feedback. Q-Submissions are used to request breakthrough designation status. 

It is an important tool for gauging FDA agreement to proposed studies and the regulatory pathway.

A Presubmission may be the first time a company interacts with the FDA and can set the tone for a successful relationship. 

Let us help you with your Presubmission!