FDA Establishment Registration
FDA establishment registration is an annual record that identifies your facility to FDA.
The record covers the device activities carried out there. It runs on FDA's fiscal year, and is renewed every year between 1 October and 31 December.
Every establishment that manufactures, repackages, relabels or remanufactures a device for the United States market must hold one, and must list the devices it ships.
We handle registration, listing and the annual renewal.
At a glance
| 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. |
| Small business rate | None. Every establishment pays the same fee. |
| Is the fee reduced for part of a year? | No. It is not divided by month. Register in September and you pay the full year. |
| Renewal window | 1 October to 31 December, every year. |
| New factory | Register within 30 days of starting to distribute devices. |
| Also required | A US Agent, if your factory 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. |
Registration is not clearance
Registration records the existence of your establishment. Clearance authorises the sale of one specific device. They are separate processes with separate fees, and holding one does not imply the other.
If you are not certain which of the two your device needs, the free device check answers it in one working day, before you spend anything.
What registration gives you
- It puts your factory in FDA's public database.
- It lets you complete the legal step every exporter must complete.
- It lets you say, truthfully, that your establishment is registered with FDA.
- It does not approve or clear any device.
- It does not let you say “FDA approved” or “FDA cleared”.
- It does not mean FDA has inspected you or checked your quality system.
- It does not replace a 510(k).
Before you register, establish whether your device also needs a 510(k). Registering first and discovering the clearance requirement afterwards is the sequence that costs companies a year.
What you need before you start
Five items. FDA will not complete your registration without all of them.
- Your factory name, address and contact details.
- A US Agent, if your factory is outside the United States.
- An owner and operator account in FDA's system.
- A product code and device class for each device you will list.
- The annual fee. FDA must receive it before your registration is complete.
What it costs
| What you pay FDA | Until 30 Sep 2026 | From 1 Oct 2026 |
|---|---|---|
| Factory 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 registration fee is flat. There is no small business rate on it. The reduced rates in the MDUFA schedule apply to submissions only, and a company qualifying for the $7,163 small business 510(k) fee still pays the full $13,785 to register.
When to register
The fee is not prorated. 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.
The renewal window: 1 October to 31 December
1 October – 31 December
Every year. Miss it and you are not registered.
Renewal runs from 1 October to 31 December each year, and the new year’s fee is paid at the same time.
An establishment that misses the window is not currently registered. Its devices are subject to refusal at the United States border, and the lapse is visible in the public database to any customer who checks.
We renew for our clients before the window closes and confirm in writing when it is done.
How long it takes
- Registration1–2 weeks
- 510(k), submission to decision130 days median
Registration is normally complete within one to two weeks of FDA receiving the fee. Device listing is submitted at the same time.
A 510(k) operates on a different scale: 130 days is the median from submission to decision across all countries. If your device requires one, that submission sets your launch date, not your registration.
What our service includes
$500, covering registration and every device listed under it. Separate from the fee you pay FDA.
- Owner and operator account set up
- Registration submitted
- Every device listed under the correct product code
- US Agent appointed if you need one
- Annual renewal handled before the window closes
- We tell you if a device you want to list needs a 510(k) first
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 factory 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.