Leverage FDA’s Q-Submission (PreSub) program to confirm eligibility, evidence, labeling, and special controls. A well-timed PreSub reduces RTA risk, avoids costly retesting, and accelerates De Novo review.
The FDA’s Q-Submission Program enables you to receive written feedback and/or meetings regarding pathway selection, clinical and bench testing plans, and proposed special controls—before launching expensive tests. The June 2023 final guidance, updated in May/June 2025, provides expanded clarity on timelines and the use of informal communications versus formal Pre-Submission (PreSub) requests.
For De Novo submissions, a PreSub meeting is an essential tool to validate key aspects of your regulatory strategy, including:
A well-timed Pre-Submission meeting can significantly reduce the risk of a Refuse to Accept (RTA) determination, minimize costly retesting, and accelerate the substantive review phase of your De Novo submission.
