FDA Establishment Registration
Registration is an annual record identifying your facility to FDA.
It covers the device activities carried out there, and it runs on FDA’s fiscal year rather than yours. Every establishment that makes, repacks, relabels or remanufactures a device for the United States market must hold one, and must list the devices it ships.
Registration, every device listed under it, and the renewal handled before the window closes. FDA’s own fee of $13,785 is separate and paid directly to them.
- The law
- 21 CFR Part 807
- Who registers
- Foreign and domestic
- FDA fee
- $13,785 a year
- Small business rate
- None on this fee
- Renewal window
- 1 Oct – 31 Dec
- Our fee
- $500, listing included
Two records. Only one lets you sell.
A registered establishment appears in FDA’s public database, which is easily mistaken for approval. It is not approval.
Records that your establishment exists.
- Scope
- The facility, and what it does
- FDA fee
- $13,785 every year
- What it judges
- No device. FDA assesses nothing you make.
Authorises the sale of one specific device.
- Scope
- That device, and no other
- FDA fee
- $28,653, or $7,163 as a small business
- What it judges
- The device itself, against a predicate.
They are separate processes with separate fees, and holding one does not imply the other. You may say your establishment is registered with FDA. You may not say your device is FDA approved or FDA cleared unless you hold a clearance for it.
Settle the 510(k) question first.
Registering first and discovering the clearance requirement afterwards is the sequence that costs companies a year.
Registration is normally complete within one to two weeks of FDA receiving the fee, and device listing is submitted at the same time. A 510(k) runs on a different scale entirely, so the free device check answers which of the two you need in one working day — before you spend anything on either.
- Registration1–2 weeks
- 510(k), submission to decision140–175 days average
Recent published data puts the 510(k) average well above FDA’s own internal goal. Registration does not shorten it, and does not substitute for it — if your device requires one, that submission sets your launch date.
Five items. FDA will not finish without all of them.
Four of them you already have. The fifth is the one that stops foreign manufacturers: registration cannot be completed without a US Agent.
We can act as yours, or file alongside the agent you already have. Either way it is in place before the registration goes in, not after FDA asks for it.
- Your facility name, address and contact details
- A US AgentOnly if your facility is outside the United States — and then it is not optional.
- An owner and operator account in FDA's system
- A product code and device class for each deviceThe code decides the class, and the class decides whether a 510(k) is required.
- The annual feeFDA must receive it before your registration is complete.
The window closes on 31 December.
Registration is renewed every year between 1 October and 31 December. An establishment that misses the window is not currently registered — there is no grace period, and FDA does not write to tell you the record has gone.
Its devices are subject to refusal at the United States border, and the lapse is visible in the public database to anyone who checks.
| Who checks it | What a lapse means to them |
|---|---|
| Customers and distributors | Checking the establishment is current before they order |
| Hospital procurement | Verifying a supplier before a contract |
| Your importer | Confirming a shipment can legally be brought in |
| The United States border | Devices from an unregistered establishment are subject to refusal |
We renew for our clients before the window closes, pay the new year’s fee at the same time, and confirm in writing when it is done.
One flat fee. No small business rate.
Every establishment pays the same amount to register, whatever its size and however many devices it lists.
| What you pay FDA | Until 30 Sep 2026 | From 1 Oct 2026 |
|---|---|---|
| Facility registration, each year | $11,423 | $13,785 |
| 510(k) submission, standard | $26,067 | $28,653 |
| 510(k) submission, small business | $6,517 | $7,163 |
The reduced rates in the MDUFA schedule apply to submissions only. A company that qualifies for the $7,163 small business 510(k) fee still pays the full $13,785 to register. These amounts go to FDA and are the same whoever files for you; our $500 is separate.
The fee is not divided by month.
An establishment registering in September pays the full annual fee for the remaining weeks of that fiscal year, then pays it again in October for the next one. Same fee, one twelfth of the cover.
So if you are not yet shipping and no customer is waiting on your registration, register in October. One payment then buys twelve months instead of six weeks.
A new facility that is already distributing does not get the choice: FDA requires registration within 30 days of starting to distribute devices, whatever month that falls in.
- You register in SeptemberAbout 4 weeksTwo full fees, six weeks apart$13,785 now, then $13,785 again on 1 October
- You register in October12 monthsOne fee$13,785, covering the whole year
Registration, listing and the renewal, for $500 a year.
One fee, however many devices. FDA’s own $13,785 is paid directly to them and is not part of our quote.
Your FDA account
We set up the owner and operator account your registration is filed under.
The registration
We submit it, and confirm when FDA has your fee and the record is complete.
Every device listed
Each device you ship, listed under the correct product code. No second FDA fee.
A US Agent
Appointed at the same time if your facility is outside the United States.
The annual renewal
Handled before the window closes, with the new year's fee paid at the same time.
The 510(k) question
We tell you if a device you want to list needs a clearance first.
Register once. We keep it current every year after that.
- $500 a year
- Listing included
- US Agent if you need one
- Renewed before the window shuts
At a glance
| What it is | An annual record identifying your facility to FDA, covering the device activities carried out there. |
|---|---|
| Who must register | Every establishment that makes, repacks, relabels or remanufactures devices for the United States market. Foreign and domestic. |
| The law | 21 CFR Part 807 |
| FDA fee | $11,423 now. $13,785 per year from 1 October 2026. |
| Renewal window | 1 October to 31 December, every year. |
| New facility | Register within 30 days of starting to distribute devices. |
| Also required | A US Agent, if your facility is outside the USA. Registration cannot be completed without one. |
| Device listing | Included. There is one annual FDA fee, not two. |
| Our fee | $500, covering registration and every device listed under it. See what it includes. |
Questions people ask
How long does registration take?
Most companies finish within one to two weeks after FDA receives the fee.
Is there a small business discount?
Not on this fee. Every establishment pays the same registration fee. The small business rate applies to 510(k) submissions.
Do we need a US Agent first?
Yes, if your facility is outside the United States. Registration cannot be completed without one.
Does registration mean our device is FDA approved?
No. You may say your establishment is registered with FDA. You may not say your device is FDA approved or FDA cleared unless you hold a clearance for it.
What if we add a new device during the year?
You update your listing. FDA does not charge an extra fee for adding a device inside a year you have already paid for.
We registered years ago and stopped paying. What now?
You register again and pay the current year's fee. We check your status in FDA's database first, free, so you know exactly where you stand before you spend anything.
Do we need to register more than one facility?
Each establishment registers separately and pays its own annual fee. Two manufacturing sites means two registrations, not one covering both.
We use a contract manufacturer. Who registers?
The facility where the device is made holds its own registration. Whether your company also needs one depends on what it does with the device. Tell us the arrangement and we will tell you who owes what, before anyone pays a fee.
What happens if we stop selling in the United States?
You stop renewing. The record lapses at the end of the fiscal year you last paid for, and your devices come off the public database with it.
Registered before, and not sure it is still current?
A lapsed registration looks exactly like no registration at the border. If you stopped paying at some point, you register again and pay the current year’s fee — but check before you assume it.
Send us your establishment name.We look up your status in FDA’s database and tell you exactly where you stand. Free, whether or not you go on to work with us.