Superagent doesn’t just answer — it dispatches specialized subagents to find, reason, and act on your behalf. Every output is cited and defensible.
Searches the FDA databases, retrieves the guidance, and surfaces the precedents that actually apply to your device.
Applies regulatory thinking to your device and your situation — not generic best practices.
Produces deliverables: cited drafts, structured comparison tables, and FDA correspondence ready for review.
Behind every answer is a network of specialist subagents, each deep in its own domain. Superagent reads your question, plans the work, and dispatches the right ones in parallel.
Calibrated to FDA’s latest guidance, recalls, and decision letters.
Your team has a near-final device profile. You need a predicate you can actually defend in front of FDA — and the comparison table to back it up.
It could be Class II under one product code, or De Novo under another. You need the pathway and the reasoning before the next leadership review.
Your draft is done. You need to know where it's weak before QA or the consultant gets to it.
Your device profile is set. You need Indications for Use language that fits your strategy — defensible, cited, and aligned with cleared precedent.
Six numbered items on an Additional Information request. The clock starts the day you read it.
You've picked your predicate. Before the SE narrative locks in, you want to know what failure patterns FDA has already seen.
“I used to spend half a day digging through FDA databases for a classification answer. Superagent gets me there in ten minutes — with citations the whole team can defend.”
“The first time I asked Superagent for De Novo precedents, it returned decisions I hadn't found in days of manual FDA searching. That's the moment I knew this would change how I support clients.”
