Ask anything.
Get a regulatory answer, with citations.
Superagent is your always-on FDA expert. Ask about classification, guidance, predicates, or your own documents — and get a sourced, defensible answer in seconds.
Would you like me to pull the 5 closest predicates cleared in the last 3 years?
Three modes. One conversation.
Ask questions
Classification, device codes, guidance documents, fee schedules, regulatory pathways — any regulatory question answered in plain language with citations.
Analyze your documents
Upload your device description, test reports, or existing draft. Superagent reads them, finds gaps, and suggests what to add — relative to what FDA expects.
Draft sections
Ask Superagent to draft an indications-for-use statement, a substantial equivalence summary, or a cover letter. Cited, structured, ready to refine.
How RA teams use Superagent every day.
Not a chatbot. A workflow tool that replaces hours of manual research with minutes of focused conversation.
Device research
Describe the device. Superagent searches all cleared 510(k)s, De Novo's and PMA's. Scores similarity across intended use, technology, and indications, and returns the top matches with a side-by-side comparison table and substantial equivalence draft.
Product code & Predicates
Superagent analyzes your device and proposes the most likely product code and predicates — with direct citations to 21 CFR and clearance history.
Guidance lookup
Ask what FDA expects for a specific device type or submission section. Superagent finds the relevant guidance documents, special controls, and recent feedback patterns — and quotes the exact passages.
Drafting Section B & C
Ask Superagent to draft the Device Description or Performance Testing sections from your device profile. It pulls applicable standards, cites relevant predicates, and produces a first draft ready for your technical review.
FDA correspondence prep
Paste in an Additional Information (AI) request or deficiency letter. Superagent reads it, identifies each outstanding item, and drafts a structured response plan with suggested citations and language.
“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.”