Your eSTAR,
drafted before your
coffee gets cold.
Complizen Submission Builder takes your device profile and works through every section of a 510(k) — scoping requirements, drafting language, tracing citations, and pre-flighting against FDA’s Refuse-to-Accept criteria.
- eSTAR-native export
- RTA pre-flight checks
- Expert review available
Pathway & scope definition
Input your device. Get your classification, product code, applicable special controls, user fees, and submission pathway — cited and ready to defend.
Automated requirement analysis
Complizen maps every applicable FDA requirement, standard, and guidance to your submission type and device category — nothing missed, nothing invented.
Section-by-section AI drafting
From indications for use to substantial equivalence narrative — AI drafts each section from your device profile and predicate history, with full citations.
Full submission traceability
Every claim links to a source document, every section maps to an eSTAR field, every version is logged. Your audit trail is built as you write.
From device profile to FDA submission — step by step.
Describe your device
Drop in your device description, intended use, and technology. Complizen confirms classification, pathway, applicable predicate pool, and user fee — in under two minutes.
Select your predicates
Superagent surfaces the top 10 cleared predicates by similarity. You confirm the top 3. Complizen starts building the comparison table immediately.
Review your section checklist
A fully-scoped eSTAR checklist appears — every section required for your pathway, pre-ranked by drafting effort, with cross-dependencies mapped.
AI drafts each section
Work through sections in any order. Complizen drafts language from your device profile, predicate documents, and applicable FDA guidance — you review and refine.
Run RTA pre-flight
Before export, Complizen checks every section against FDA's current Refuse-to-Accept checklist. Any gaps surface with a suggested fix — not a vague warning.
Export or send for expert review
Download your eSTAR package ready for the FDA portal. Or, with one click, send it to a Complizen FDA expert for a full section-by-section review before you submit.
Working solo? Skip this.
Want a senior FDA consultant to review every section before you submit?
One click. A Complizen-affiliated FDA consultant reviews your full submission — section by section, comment by comment — and signs off before you upload. This is the same service as our done-for-you 510(k) track, available to self-builders.