For FDA medical device submissions
A 510(k) is months of research and hundreds of pages. Regway reads FDA's own device records, finds your predicates and drafts every eSTAR section with citations. You stay the expert, and nothing goes out until you've approved it.
The source
Regway keeps a local copy and searches it in full. When it cites a K-number, a guidance document or a 21 CFR section, you can open the source and check it.
How it works
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Tell Regway what you're building, the way you'd tell a colleague. It finds the classification regulation, the product code and the right pathway in FDA's database, and explains why.
“A single-use neurovascular microcatheter for delivering coils and contrast to small vessels.”
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Regway proposes cleared devices that match yours, compares them side by side and traces each one's clearance history back five levels. You pick; it remembers why.
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Each section is drafted from your device, your predicates and FDA guidance, then handed to you. Approve it, ask for more detail, or have it rewritten. Anything only you can know is left marked for you.
Substantial Equivalence Discussion
The AcuTip NV-200 has the same intended use as the primary predicate K261889; the hydrophilic coating differs and is addressed by bench testing per ISO 10555-1.
[Needed from you: tip-flexibility result, N=30]
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Before anything is built, a check modeled on FDA's acceptance review looks for missing sections, leftover placeholders and broken citations. Then you get a package ordered by eSTAR section, with step-by-step filing instructions.
How to file this with FDA
The whole submission
Your outline follows eSTAR, so you always know what's approved, what's waiting for you and what's left. No spreadsheet of status updates.
Example: a microcatheter 510(k)
7 of 15 sections approved
Who it's for
Whether you're filing your own device, filing for clients, or deciding whether to invest in one.
Your first 510(k), without a regulatory department.
Your path on day one
Classification, product code and pathway from FDA's database, with the reasoning.
Real predicates
Cleared devices compared side by side, with lineage five levels deep.
Drafts you review
Every eSTAR section drafted from your device and FDA guidance.
Nothing missing
A pre-filing check, PDF and Word export, and a traceability matrix.
Every client's submission, in one workspace.
Clients, organized
Each client has its own projects, status and last activity.
One-click switching
Switch clients from the sidebar; new projects file under the one you're on.
Your brand
PDF and Word exports with your logo, colors and firm name on every page.
Client review links
Clients comment on or approve each section, no account needed.
Regulatory due diligence in minutes, not weeks.
Path to market
Classification and likely pathway: 510(k), De Novo or PMA.
How crowded it is
Clearances for the product code, and who holds them.
Time and risk
Review times against the all-codes median, plus recalls and adverse events.
Numbers you can check
Every figure traced to its FDA table; track portfolio companies as clients.
Export the design-controls traceability matrix into your quality system, or pull project data into your own tools with an organization API key.
Coverage
We started with FDA device filings because they're the most structured. Pharma, clinical trials and quality are in development.
No. Regway prepares the package and tells you exactly how to file it. You, or your regulatory lead, review it, sign it and submit it to FDA through the CDRH Portal.
No. Anything only you can know, such as test data, establishment numbers or dates, is left clearly marked in the draft and listed under “Still needed from you”. The package isn't called ready while any remain.
From a local copy of FDA's public device records: 510(k) clearances, PMA approvals, De Novo grants, classifications, recalls, adverse-event reports and the full text of FDA guidance. Citations link to the source.
No. Your documents are used for your project only. You can export or delete them at any time.
Medical devices today: 510(k) preparation, plus De Novo and PMA research. Pharma, clinical trials and quality are in development.
Yes. File each project under a client or portfolio company, export documents under your firm's branding, and share a review link so your client can comment on or approve sections without an account.
Yes. The due diligence report needs only a device description or a product code. It summarizes the pathway, predicate landscape, review times and post-market signals from FDA's public records.
It's free to start. Create an account and run your first device through classification and predicates.
In a few minutes you'll have a classification, real predicates and an outline of every section FDA expects.
Free to start. You approve everything before it goes to FDA.