FDA Q-Submission & Pre-Submission Consulting

We determine which uncertainties are worth taking to FDA, frame focused questions and provide enough technical context for FDA feedback to be actionable before major testing or submission decisions are locked.

Plan Your FDA Pre-Submission

What This Service Is

The Q-Submission program allows sponsors to seek FDA feedback on specific regulatory or technical questions before a future submission. The value of the interaction depends heavily on the quality of the question, the supporting context and whether FDA feedback can meaningfully influence the program.

When It Is Particularly Valuable

When the regulatory pathway is uncertain

When a novel technology or intended use is involved

When predicate strategy is complex

When the proposed testing method or acceptance criteria are uncertain

When clinical or IVD performance study design requires FDA input

Before committing significant time or budget to a high-risk evidence plan

How We Prepare the Interaction

Identify the decisions that would benefit from FDA feedback

Develop focused questions that FDA can answer meaningfully

Prepare the device, technology and regulatory background

Present proposed testing or evidence strategy

Prepare the briefing package and supporting rationale

Prepare the team for the FDA meeting

Assess FDA feedback and translate it into the submission plan

Our Difference

Targeted, Decisive Questions for Actionable Feedback

We do not send broad questions to FDA. We first decide what uncertainty needs to be resolved and what decision FDA's feedback should enable.

Q-Submission Timeline

~70-75 calendar days to FDA feedback / meeting
Written feedback or teleconference / videoconference
FDA user fee: $0 (No user fee for Pre-Submissions)

Have Regulatory Questions?

Engage FDA early to validate your testing plan or clinical evidence strategy.

Plan Pre-Submission

Ready to Align with the FDA?

Let our experienced team craft a targeted Q-Submission briefing package that secures definitive answers.

Book a Consultation