+1 917 960 9666info@kgpfda.com
KGP FDA
Free Preliminary Assessment

FDA – Medical Devices

Device Listing

Fee: $249 / product

Registered device establishments list each device in commercial distribution and the activities performed at the establishment with FDA. Listings are verified each year between October 1 and December 31, even if nothing has changed. Foreign establishments must list their devices before they are imported.

Who Is Obligated?

All device establishments required to register with FDA.

What We Do

  • We identify the product code and premarket status of your devices.
  • We file the listing on your behalf.
  • We update the listings for new products, new activities or products no longer distributed.

What You Receive

  • Device listing records
  • Annual verification reminder
Fill in the application formAsk a question firstAll United States services

FDA Medical Device Listing Application

Product code, class, premarket clearance or approval, and brand name details for listing your devices with FDA.

  1. 1 Preliminary Information
  2. 2 Devices
  3. 3 Submit
1. Preliminary Information
Is your establishment registered with FDA? *

Listing is done through a registered establishment. If you are not registered, also fill out the establishment registration form.

Your details are used only to prepare your application. An unfinished application is kept in this tab.

Frequently Asked Questions

When must device listing be done?
Foreign establishments must list their devices before they are imported.
Do I still need to do anything if nothing has changed?
Yes. Listings are verified each year between October 1 and December 31, even if nothing has changed.
What happens when I add a new model?
The listing is updated for a new product, a new activity or a product no longer distributed. You only need to notify us.

Sources: 21 CFR 807.22; 21 CFR 807.28; FDA: Device Registration and Listing.