A guided, AI-powered path from device description to submission-ready 510(k) — built on a real FDA database of clearances, classifications, and guidance, with you in control at every step.
510(k) clearances indexed
Device classifications
Guided workflow steps
Predicate chain levels traced
Supporting all major FDA submission types
Purpose-built tools for FDA regulatory professionals, powered by the latest AI technology.
A 7-step guided path from device intake to export: classification, predicate selection, blueprint, gap analysis, drafting, and final review — with you approving every step.
Search 510(k) clearances, PMA approvals, De Novo grants, classifications, recalls, and adverse events — semantically, with links to original FDA PDFs.
Trace a predicate's lineage up to five levels deep, compare candidates side-by-side, and pick predicates backed by real clearance data.
Section drafts cite the relevant FDA guidance documents and 21 CFR sections, with full traceability back to source requirements.
Upload what you have. Regway compares it against your submission blueprint and shows exactly what's complete, partial, or missing.
The AI proposes, you decide. Every tool call, pathway choice, and draft is reviewable and approvable — nothing ships without you.
From document upload to submission-ready output in minutes, not months.
Tell Regway what you're building. It classifies your device against the FDA database, finds your product code, and recommends a submission pathway.
Review real predicate candidates with traced clearance chains, pick yours, and get a section-by-section submission checklist with a gap analysis of your documents.
Approve AI-drafted sections grounded in FDA guidance — accept, edit, or regenerate each one — then export a compiled, submission-ready package.
From 510(k) submissions to pre-sub meetings, Regway handles the heavy lifting so you can focus on strategy.
Run the full guided workflow: classify your device, select predicates from real clearance data, and draft substantial equivalence arguments.
Search clearances semantically, trace predicate chains five levels deep, and read the original 510(k) summary PDFs without leaving the app.
Upload your existing documents and get an instant gap analysis against your submission blueprint — complete, partial, or missing, per section.
Generic AI tools don't understand FDA regulations. Regway is purpose-built for the regulatory world.
Stop wrestling with FDA paperwork. Let AI handle the heavy lifting while you focus on getting your product to market.