FDA Pre-Submission (Q-Sub) Support
Practical RA supports manufacturers with the planning and preparation of FDA pre-submission packages to clarify regulatory expectations prior to formal submission.
Why Pre-Submissions Matter
FDA pre-submissions provide manufacturers with an opportunity to engage with the Agency early in the development or regulatory planning process. Pre-subs are commonly used to obtain feedback on study design, performance testing, clinical evidence expectations, and overall regulatory strategy.
Used effectively, a pre-submission can reduce uncertainty and help manufacturers avoid costly misalignment with FDA expectations. However, poorly planned pre-subs can be ineffective, particularly where questions are too broad or insufficiently supported by background information.
FDA expects pre-submission questions to be specific, focused, and supported by sufficient context to enable meaningful feedback. Submissions that lack clarity or request advice outside FDA’s remit may result in limited or non-actionable responses.
Pre-subs are particularly valuable for novel technologies, devices with complex performance testing requirements, or where clinical evidence expectations are unclear. They can also be used strategically to confirm predicate suitability or to discuss changes to previously cleared devices.
How Practical RA Can Support
Practical RA supports pre-submission activities, including:
- Pre-submission strategy and planning
- Drafting focused regulatory questions
- Preparation of briefing documents
- Review of FDA feedback and follow-up planning
Our focus is on producing documentation that is clear, consistent, and defensible from a regulatory review perspective.
