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21 CFR Part 807 · Establishment registration · Device listing · US Agent

FDA establishment registration and device listing, done right and on time

We register your establishment, list your devices and act as your US Agent — so US Customs clears your shipments and your devices appear in FDA's public database without delays.

Get a free registration quote See the process
Oct 1 – Dec 31annual renewal window, every year
30 daysto register after you start operating
The basics

What is FDA medical device registration and listing?

Owners and operators of establishments that make or distribute medical devices for the US market must register their establishment with FDA every year. This is called establishment registration, under 21 CFR Part 807.

Registered establishments must also list the devices they handle and the activities they perform on them. Most devices need a 510(k), De Novo, PMA, PDP or HDE number before they can be listed. US Customs and Border Protection checks registration and listing before foreign devices enter the US.

Establishment registrationYour facility registered in FDA's FURLS system and renewed every year.
Device listingEach device, product code, trade name and model listed correctly.
US Agent serviceA US contact for FDA, required for every foreign establishment.

Registration is not FDA approval

Registering your establishment and listing your devices does not mean FDA has cleared or approved them. FDA does not issue registration certificates, and marketing a device as "FDA registered" in a way that suggests approval is misleading.

If your device needs a 510(k), De Novo or PMA, that must be in place before you list it. We check your premarket status first, so your listing goes through cleanly.

Who must register

Who needs FDA registration and listing?

If your establishment does any of the following for devices sold in the US, FDA expects you to register — whether you are based in the US or abroad.

01
ManufacturersDomestic and foreign manufacturers of finished devices, including contract manufacturers.
02
Specification developersCompanies that design the device and have someone else make it.
03
Initial importersThe first US importer that takes ownership of a foreign device.
04
Foreign exportersCompanies outside the US that export devices made by others into the US.
05
Repackagers & relabelersFirms that change a device's package or labelling.
06
ReprocessorsFirms that reprocess single-use devices for reuse.
07
Contract sterilizersFirms that sterilize devices for other companies.
08
Export-only manufacturersUS makers of devices intended only for export.
Our services

Our FDA registration and listing services

From your first registration to every yearly renewal, we keep your FDA records complete and current.

Establishment registrationFURLS account set-up and your first registration with FDA.
Device listingProduct codes, regulation numbers, trade names and models listed for every device.
Annual renewalRenewal filed between 1 October and 31 December so you never lapse.
US AgentWe act as your US Agent and answer FDA on your behalf, any time.
User fee paymentHelp paying the annual registration fee and matching the payment to your registration.
Updates & transfersChanges to owner, address, devices or US Agent, filed on time.
How it works

Our registration and listing process, step by step

  1. 1

    Check DUNS number

    Day 1

    Confirm your facility's DUNS number matches your legal name and address, as FDA requires.

  2. 2

    Classify your devices

    Day 1–2

    Identify each device's product code and regulation number, and confirm any 510(k), De Novo or PMA number.

  3. 3

    Pay the FDA fee

    Before registering

    Pay the annual establishment registration fee and keep the payment confirmation (PIN and PCN).

  4. 4

    Create FURLS account & register

    After payment

    Set up your FDA Unified Registration and Listing System account and submit your establishment registration.

  5. 5

    List your devices

    Same session

    Enter device names, trade names and models, and the activities you perform on each one.

  6. 6

    Verify on FDA's database

    Once published

    Check your registration and listing details in FDA's public database and share the record with you.

  7. 7

    Renew every year

    1 Oct – 31 Dec

    We remind you, renew your registration, review your listings and file any updates.

Key deadlines

FDA registration and listing deadlines

Missing a deadline can stop your devices at the US border. These are the dates we track for you.

EventDeadlineWhat you need to doHow we help
New establishmentWithin 30 daysRegister and list once you start an activity that requires registrationFull set-up: DUNS check, fee, FURLS, listing
Annual renewal1 Oct – 31 DecRenew registration, pay the yearly fee and review listingsReminders, fee payment support, renewal filing
Device listing changesJune & DecemberUpdate listings for new, changed or discontinued devicesListing updates filed on time
US Agent changePromptlyUpdate your US Agent details in FURLSWe take over as your US Agent and update FDA
Owner or address changeWithin 30 daysUpdate your establishment registrationRegistration update and record check

Official references: FDA's Device Registration and Listing page and 21 CFR Part 807.

Why REGHELPS

Your FDA US Agent, available when FDA calls

Foreign manufacturers and exporters rely on us to register quickly and answer FDA whenever it asks for information.

Device expertsA large team of device consultants and project managers, not a mailbox service.
Global reachUS Agent and FDA support for foreign manufacturers worldwide.
Always responsiveWe reply to FDA requests quickly so your shipments are not held.
Clear pricingClear scope and fees agreed up front.

Related FDA services

FDA 510(k) Premarket Notification FDA Medical Device Classification US FDA Consultants

FDA registration and listing FAQs

Who must register a medical device establishment with FDA?

Manufacturers, specification developers, initial importers, foreign exporters, repackagers, relabelers, reprocessors of single-use devices, contract sterilizers and US manufacturers of export-only devices must register their establishment with FDA under 21 CFR Part 807.

When do I need to renew my FDA registration?

Every year, between 1 October and 31 December. You must pay the annual registration fee before you can renew.

Does FDA issue a registration certificate?

No. FDA does not issue registration certificates, and registration does not mean FDA has approved or cleared your device. You can confirm your registration and listing in FDA's public database.

Do I need a 510(k) before listing my device?

Most Class II and some Class I and III devices need a 510(k), De Novo, PMA, PDP or HDE number before listing. Many Class I and some Class II devices are exempt. We check your device's status before listing.

Do foreign manufacturers need a US Agent?

Yes. Every foreign establishment must name a US Agent when registering. REGHELPS can act as your US Agent and respond to FDA on your behalf.

Can I transfer my US Agent to REGHELPS?

Yes. Manufacturers and exporters can change their US Agent at any time. Share your FDA FURLS account access with us and we will update the US Agent information.

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