Regulatory Affairs
FDA Pre-Submission (Q-Sub) Support
Get FDA alignment on your predicate and testing plan before you spend on testing.
What It Is
A Pre-Submission (part of FDA’s Q-Submission program) is a formal request for written feedback, usually followed by a meeting, on specific questions about your device before you make a regulatory submission. It is the single most effective tool for de-risking a program: you confirm your regulatory pathway, predicate strategy, and testing plan with FDA before you invest in testing that might otherwise have to be repeated.
When You Need It
You should consider a Pre-Sub whenever there is uncertainty about your predicate, your testing plan, a novel technology, an unclear classification, or a De Novo or IDE strategy. The cost of a Pre-Sub is almost always smaller than the cost of repeating a test program because it did not match FDA expectations.
What We Do
We frame the right questions — the ones that actually reduce your risk — and write a focused Pre-Sub package: device description, proposed pathway, testing plan, and specific questions for FDA. We prepare you for the meeting, run point on the agency interaction, and translate FDA’s feedback into a concrete, costed plan you can execute.
We Live It, Not Just Advise It
Because our family runs the testing, our Pre-Sub questions are grounded in what the testing actually involves — cycle development, residual methods, package validation timelines. We ask FDA the questions that change what you have to build, not generic ones, because we know what building it costs.
Frequently Asked Questions
How long does a Pre-Submission take?
FDA’s goal is to provide written feedback within 70 to 75 days of receiving a Pre-Sub, with a meeting (if requested) around that time. Building a strong Pre-Sub package typically takes us a few weeks, depending on how well-defined the device and questions are.
Is FDA feedback from a Pre-Sub binding?
It is non-binding, but in practice it is highly valuable and FDA generally honors the alignment reached unless circumstances change. Documented Pre-Sub feedback is one of the strongest pieces of evidence you can carry into your eventual submission.
How many questions should I ask in a Pre-Sub?
Focused is better than exhaustive. A tight set of three to five high-leverage questions about predicate, testing, and pathway gets clearer, more useful answers than a long list. We help you choose the questions that actually change your plan.
Ready to Talk Through Your Pre-Sub / Q-Sub Project?
Tell us where you are in the process. We respond within one business day.
Request a ConsultThe Boulder BioMed Family
One campus, one quality system. We manufacture, sterilize, and test medical devices in-house — so our regulatory and quality work is grounded in operations, not theory.