Get the FDA on your side
before you submit.
A Pre-Submission (Q-Sub) meeting can make or break your clearance timeline. Complizen helps you build a strategic Q-Sub package — formulating the right questions, anticipating reviewer concerns, and drafting a submission that already reflects FDA's feedback before you send it.
From “should I even file a Q-Sub?” to “FDA meeting confirmed.”
Decide if a Q-Sub is right for you
Not every submission needs a Pre-Sub. Superagent analyzes your device type, novelty, and pathway to give you a clear recommendation — including which questions are worth asking and which FDA can't answer pre-submission.
Draft your Q-Sub package
Drafting Studio builds the package: device description, proposed intended use, proposed regulatory pathway, proposed testing strategy, and your specific questions to FDA — all structured to the Q-Sub template FDA expects.
Formulate the right questions
Superagent analyzes similar Q-Sub outcomes (where public) and your device's risk profile to suggest what questions will get the most useful answers from FDA — and what's likely to generate a non-response or a “defer to submission.”
Anticipate reviewer concerns
Based on your device type, MAUDE history, and predicate landscape, Complizen surfaces the questions FDA is most likely to ask about — so you can address them proactively in the package or in your testing plan.
Incorporate FDA feedback
After your meeting, upload FDA's written responses. Superagent reads the feedback and updates your submission plan — flagging new requirements, updating predicate recommendations, and revising your testing strategy accordingly.
Reduce review time
Submissions with a Pre-Sub meeting on record are statistically reviewed faster. FDA reviewers arrive with context — your meeting minutes are part of the file.
Eliminate surprises
The most expensive AI requests come from testing strategies FDA never agreed to. A Q-Sub locks in your testing approach before you run it.
De-risk novel devices
For De Novo and novel Class III devices, a Q-Sub is often the difference between 12 months and 36 months to clearance. Don't skip it.