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.
Each device is listed under its FDA product code. Both records are required, both are submitted together, and one annual fee covers them.
We identify the correct product code for each device, and check it before we submit.
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. |
Registration, listing and clearance are three different things
Three obligations are routinely treated as one. They are separate, and only the third authorises a sale.
| Obligation | What it tells FDA | FDA fee | Do you need it? |
|---|---|---|---|
| Registration | Your factory 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.
What gets listed
Devices are listed by FDA product code, not by model name. One product code usually covers several models of the same device.
The product code determines the device class. The class determines whether a 510(k) is required. No other field you enter carries that consequence.
An incorrect code produces one of two outcomes. You pay for a submission that was never required, or you ship a device without a clearance that was.
Your listing is public
The registration and listing database is public and searchable by anyone. Customers, distributors and hospital procurement teams use it to verify a supplier before placing an order.
It is equally visible to FDA. A device listed under a product code that requires a 510(k), by an establishment holding no clearance for it, is a discrepancy anyone can find in the public record.
We confirm the product code and the clearance requirement before submitting any listing.
When you must update your listing
Four events require an update.
- You start sending a new device to the United States.
- You stop sending a device you previously listed.
- A device's product code changes.
- Your establishment details change.
Adding a device inside a year you have already paid for does not cost another FDA fee.
What our service includes
Listing is usually quoted alongside registration. Send us your device range and we will price both together.
- We identify the correct product code for each device
- We confirm the class and whether a 510(k) is required before listing
- We submit the listing
- We update it whenever your range changes
- We check your existing listings for wrong codes
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. This is one of the most 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.