From device profile
to submitted eSTAR.
End to end.
This is the Solutions-side story of the Submission Builder: the full workflow narrative from your first device description to the moment you hit submit on the FDA portal. No step skipped, no handoff to a consultant required.
Every step of the submission, in order.
Device scope & classification
Describe your device. Complizen confirms the class, product code, pathway, and user fee. Classification rationale document ready in minutes.
Predicate selection
AI-ranked shortlist of cleared predicates with similarity scoring. Select your top 3. Comparison table auto-generated.
Testing plan
Complizen maps applicable test standards from your predicates and device type. Bench, biocompatibility, EMC, software — scoped and prioritized.
Section-by-section drafting
Work through every eSTAR section with AI drafting. From cover letter to performance testing summary — cited, structured, and ready to review.
Team review & sign-off
Invite your team or external consultant. Threaded comments, section-level approvals, version locking. Full audit trail throughout.
RTA pre-flight & eSTAR export
Pre-flight check against FDA's Refuse-to-Accept criteria. Export your complete eSTAR package — or send for expert review with one click.
“We’ll build your 510(k). You just show up for FDA.”
Our done-for-you 510(k) service pairs the Submission Builder engine with a senior FDA expert who reviews every section before you submit. Fixed fee. Fixed timeline.
See the 510(k) service →