All our services, priced in one page.
Nine services. Fixed fees, agreed in writing before anything starts. No hourly billing, anywhere.
Every fee named, and nothing bundled in that is not ours — FDA charges its own fees, paid straight to FDA and never marked up by us.
- To start
- Two services, free
- 510(k) build
- $11,000 to $20,000
- Billing
- Fixed once scoped
- Hourly billing
- None, on anything
- Annual, to us
- $1,500 a year
- FDA's fee
- Separate, never marked up
Nine services. Nine prices.
Fixed, transparent, and defined before we begin.
Prices are for a single device and are confirmed in writing before work begins. FDA user fees, testing-laboratory costs and translation are passed through at cost and quoted separately — FDA’s own rates are in our fee calculator, and in the Federal Register notice (91 FR 48134) they are published in.
Four things you will never be charged for.
A fixed price is only fixed if the exceptions are named. These are ours, and there are no others.
Hourly billing
There is none, on anything we sell. A price is agreed in writing before work starts, and it does not move once it has.
FDA coming back with questions
Drafting the response to an Additional Information request is inside the original 510(k) fee — not a change order, and not billed by the hour while the review is on hold.
A markup on FDA's fee
FDA's fees are paid directly to FDA. We never handle the money, never add to it, and never bundle it into a quote to make ours look smaller.
Finding out what you need
The device check and the gap assessment cost nothing. You learn what applies to you, and what it will cost, before you commit to any of it.
Every price on this page is the price.
- Fixed once scoped
- No hourly billing
- FDA's fee never marked up
- Two services free
Not sure which you need?
- If
You are not certain your device needs a 510(k) at all.
- If
You know you need one, but not what it will cost you.
- If
Your device is finished and you are ready to file.
Start with the 510(k) build$11,000–$20,000 - If
Your device is still in design and the decisions keep coming.
Start with regulatory advisoryFrom $950 a month - If
You already sell in the US and only need to stay on the register.
Registration and a US Agent$1,500 a year
None of these quite fit?
Describe your device and we will tell you which of these applies — or that none of them does, which is an answer we give more often than you might expect.
Get an exact quoteQuestions people ask
Do I pay FDA a separate fee on top of your price?
Yes, for anything that requires an FDA submission or registration. Our fee covers our work. FDA's fee is paid directly to FDA, is never marked up, and is never bundled into a Complizen quote.
How much does a 510(k) submission cost with Complizen?
$11,000 to $20,000, fixed the moment your scope is agreed — no hourly billing and no revised invoice partway through. Where you land in that range depends on your predicate, the evidence you already hold, and how many sections need drafting from nothing. The free gap assessment settles all three before we quote.
Why are label review and UDI submission quoted instead of fixed?
Both scale with something that varies by device — how many labels, how many device records. We quote per device family or per submission batch rather than posting one number that would be wrong for most companies.
Is there a free way to start?
Two. The free device check tells you your product code, class and whether a 510(k) is required, usually in about two minutes. The gap assessment goes further: it reads your actual documents and tells you what closing the difference costs. Neither costs anything, and the second is what turns our range into your number.
What happens if the scope changes partway through?
The fixed price does not move for work already scoped. If you add a device, add an indication, or ask for something outside what was agreed, we quote that separately before doing it — you will never find it on an invoice you did not approve first.
Is regulatory advisory a contract?
No. It is month to month: $950 a month for two expert hours, $1,450 for four, or $4,073 for fifteen. Scale up for a heavy design period, scale down or pause when the device is sitting still.
Do the annual fees renew automatically?
The US Agent appointment and the establishment registration are annual, and we file the renewals on schedule rather than waiting for you to remember. FDA's registration window closes on 31 December every year, and a lapse takes your devices off the register — which is a customs problem, not a paperwork one.
Are these prices per device?
Yes. Every fixed price on this page is for a single device, and the establishment registration is the one exception — the $500 covers the facility and every device listed under it. If you are bringing a family of devices, say so early: it usually costs less than the same devices priced one at a time.
We are based outside the United States. Does anything change?
The prices do not. You do need a US Agent, which is the $1,000 line, and you do not need a US company or a US office — your foreign entity is the applicant and the clearance is issued in its name. Most of the companies we work with are outside the US.
Does this page cover the price of the software?
No. This is consulting pricing — the regulatory experts who do the work. The Complizen.ai platform is priced separately, from a free tier upward.