Three different things
| What it is | Who needs it | |
|---|---|---|
| Establishment registration | Tells FDA who you are and where you make or handle devices. Renewed every year. | Most establishments that make or distribute devices for the U.S. |
| Device listing | Tells FDA which devices each establishment handles. | Every registered establishment, for each device |
| 510(k) clearance | FDA's review showing a device is substantially equivalent to a device already legally sold. | Most Class II and some Class I devices |
Registration and listing are needed for almost every device. A 510(k) depends on the device's class.
Which class is your device?
- Class I (low risk), such as many bandages and manual instruments: most are exempt from 510(k). They still need registration and listing.
- Class II (moderate risk), such as many powered devices, test kits and infusion pumps: most need a 510(k). Some are exempt.
- Class III (high risk), such as implantable life-supporting devices: usually need premarket approval (PMA).
The class and whether a 510(k) is needed come from the device's product code in FDA's classification database. New low-to-moderate-risk devices with no similar device on the market may use the De Novo pathway instead.
What a 510(k) involves
- Choosing a "predicate", a device already legally sold in the U.S. that yours is compared with
- Testing and data showing your device is as safe and effective, such as performance, biocompatibility, software or electrical safety
- A user fee paid to FDA: for fiscal year 2027, $28,653, or $7,163 for qualifying small businesses
When FDA agrees, it "clears" the device and gives it a 510(k) number. Registration and listing come after or alongside it, and the listing refers to the 510(k) number.
Questions
My device is Class I. Do I still need to register?
Usually yes. Most Class I devices are exempt from 510(k), but the establishment must still register every year and list the device.
Does a 510(k) replace registration?
No. A 510(k) clears the device. The establishments that make or distribute it must still register and list it.
Does Regovant prepare 510(k)s?
We register establishments, list devices, act as U.S. Agent and check whether a 510(k) is needed. 510(k) preparation is quoted separately.
How Regovant can help
Regovant LLC registers device establishments, lists devices and acts as U.S. Agent for $369 a year, plus $49 per device listing. FDA's own annual fee is paid separately, and we walk you through it. See the medical device service, all guides or prices.