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
PMA approvals indexed
Guided workflow steps
Predicate chain levels traced
Built on a real FDA database — 279K+ records across
Purpose-built tools for FDA regulatory professionals, powered by the latest AI technology.
A consultant-grade program that runs before you file: classify, set predicate and testing strategy, assess risk — then produce a Regulatory Strategy Report and an FDA Pre-Submission (Q-Sub) package, and hand off pre-filled into the 510(k).
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 full-text guidance — 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 are grounded in the full text of FDA guidance and cite 21 CFR sections and predicate K-numbers — with citations validated against the FDA database.
Upload what you have. Regway assesses each blueprint section against your documents with an evidence quote and confidence level — complete, partial, or missing.
Organizes your submission to FDA's eSTAR sections (A–V) with Forms 3514 & 3881 drafted and a completeness pre-flight modeled on FDA's technical screening — ready to transfer into FDA's eSTAR PDF and file via the CDRH Portal.
For AI-enabled devices, Regway adds the documentation FDA expects — model card, data & bias, performance validation, monitoring — plus a Predetermined Change Control Plan builder.
An automated RTA-style review checks section coverage, eSTAR completeness, leftover placeholders, citation validity, and cross-section consistency before you compile.
The AI proposes, you decide — every draft is reviewable and approvable. Export an AI audit trail and validation dossier for your quality system.
From a plain-language device description to a submission-ready package — Regway walks you through every step, and nothing advances without your approval.
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, lock in your blueprint, then run a gap analysis that maps your own documents to every required section.
Approve AI-drafted sections grounded in FDA guidance — accept, edit, or regenerate each one — then compile and export a 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.