FDA Device Listing
Listing records which devices your establishment ships to the United States.
Registration and listing are separate records. Registration records that your establishment exists; listing records the devices it ships. Both are required, both are submitted together, and one annual fee covers them.
Listing is included in the $500 establishment registration, which covers every device listed under it. We identify the correct product code, and check it before we submit.
- The law
- 21 CFR Part 807
- Listed by
- FDA product code
- FDA fee to list
- $0
- Our fee
- In the $500 registration
- Visibility
- Public and searchable
- Update when
- Your range changes
Three records. Only one authorises a sale.
They are routinely quoted as one obligation and priced as one line. They are three, and they do different things.
| Obligation | What it tells FDA | FDA fee | Do you need it? |
|---|---|---|---|
| Registration | Your facility exists | $13,785 each year | Always, if you sell in the USA |
| Listing | Which devices you send | Included in the above | Almost always |
| 510(k) clearance | That one specific device may be sold | $28,653, or $7,163 as a small business | Depends on the device |
An establishment can be correctly registered, with its devices correctly listed, and still be prohibited from selling them. That is the position of any company whose device requires a 510(k) it does not hold.
Devices are listed by code, not by model name.
One FDA product code usually covers several models of the same device, so a range that looks like three products to your sales team is often a single line in your listing.
Which models sit under one code, and which need their own, is the first thing we work out.
The product code decides everything after it.
The code determines the device class. The class determines whether a 510(k) is required. No other field you enter carries that consequence.
Anyone can search what you have listed.
The registration and listing database is public and searchable. Customers, distributors and hospital procurement teams use it to verify a supplier before placing an order, which is the half of this worth having.
It is equally visible to FDA. A device listed under a code that requires a 510(k), by an establishment holding no clearance for it, is a discrepancy anyone can find in the public record.
| Who searches it | What they read it for |
|---|---|
| Customers and distributors | Verifying a supplier before placing an order |
| Hospital procurement | Confirming the establishment is registered |
| Your competitors | Seeing exactly what you sell |
| Importers and brokers | Checking the establishment before an import entry |
| FDA | Comparing your product codes against the clearances you hold |
We confirm the product code and the clearance requirement before submitting any listing.
Four events require an update.
A listing describes what you ship today. When that changes, the record has to change with it.
A device added
You start sending a new device to the United States.
A device withdrawn
You stop sending a device you previously listed.
A code change
A device's product code changes.
Establishment details
The details FDA holds about your facility change.
Listing, with the code checked first.
No separate fee. All of it is covered by the $500 establishment registration, however many devices sit under it.
Product code
We identify the correct code for each device you send to the United States.
Class check
We confirm the class, and whether a 510(k) is required, before anything is filed.
The submission
We submit the listing alongside your establishment registration.
Updates
We update it whenever your range changes, at no additional FDA fee.
Existing listings
We check what you already have listed, and tell you if a code looks wrong.
Listing is the easy part. The code it goes under is the work.
- $0 FDA fee
- Included in registration
- Code checked before filing
- Updates all year
At a glance
| What it is | A record with FDA of each device your establishment sends to the United States, or offers for import. |
|---|---|
| The law | 21 CFR Part 807 |
| FDA fee | None on its own. One annual establishment registration fee covers both registration and listing. |
| Who must list | Most establishments that must register. A few, such as initial importers, register but do not list. |
| What is listed | Each device, under its FDA product code. |
| Is it public? | Yes. Your listing appears in FDA's public database and anyone can search it. |
| When to update | When you add a device, stop selling one, or change its product code. |
| Our fee | Included in the $500 registration fee, which covers every device listed under it. |
Questions people ask
Is there a separate fee for listing?
No. One annual establishment registration fee covers both registration and listing.
Do we list every model separately?
You list by product code. Several models of the same device usually sit under one code. We check yours before submitting.
What if we list a device that needs a 510(k) we do not have?
Your listing is public, so FDA can see it. In our work, this is one of the more common ways a company draws attention to a gap. We check before we list.
Can we list a device we have not started selling yet?
Listing is for devices you send to the United States or offer for import. Ask us before listing anything you have not started selling.
Who can see our listing?
Anyone. It is a public FDA database.
We think our existing listing has the wrong code. Can you check?
Yes. Send us your registration number. We will look up every device you have listed and tell you if a code looks wrong. Free.
Already listed, and not sure the codes are right?
A wrong code is not something FDA writes to tell you about. It sits in the public record until someone compares it with what you are cleared to sell.
Send us your registration number. We will look up every device you have listed and tell you if a code looks wrong. Free, whether or not you go on to work with us.