[Home](/)/[Resources](/resources)/US FDA Registration and Listing

USFDA Registration

# US FDA Registration and Listing

FDA registration and listing are mandatory for medical device establishments. Understanding facility registration, device listing, and annual requirements is essential for compliance.

Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fus-fda-registration-and-listing)

At a glance

Key requirements

4

Process steps

6

FAQs

5

## Key requirements

### Facility Registration

All establishments that manufacture, prepare, propagate, compound, or process medical devices must register with FDA.

**Applies to:** Medical device manufacturers, repackers, relabelers, and certain other facilities

### Device Listing

Each medical device intended for commercial distribution must be listed with FDA with appropriate product codes.

**Applies to:** All medical devices for commercial distribution

### Annual Registration

Facility registration must be renewed annually between October 1 and December 31 each year.

**Applies to:** All registered facilities

### Initial Registration

New facilities must register before beginning operations or distributing devices.

**Applies to:** New medical device establishments

## Registration process

01

Obtain DUNS Number

Obtain a DUNS (Data Universal Numbering System) number for your business from Dun & Bradstreet.

02

Create FURLS Account

Create an account in FDA's Unified Registration and Listing System (FURLS).

03

Complete Registration

Submit facility registration information including business details, activities, and contact information.

04

List Devices

List each device with appropriate product codes and classification information.

05

Pay Fees

Pay registration fees for each facility. Fee structure varies by facility type.

06

Receive Confirmation

Receive registration confirmation and registration number from FDA.

## Listing requirements

Product Code

Each device must be listed with the appropriate FDA product code based on device classification and intended use.

Classification

Device classification (Class I, II, or III) must be provided for each listed device.

Proprietary Name

The trade name or brand name of the device must be provided.

Pre-Market Submission

Information about pre-market submission (510(k), PMA, etc.) must be provided if applicable.

## Common compliance mistakes

Not registering before beginning operations - registration is required before commercial distribution

Incorrect product codes - must use correct FDA product codes for device classification

Missing annual renewal - registration must be renewed annually October-December

Not updating device listings - must update listings when devices change

Using wrong facility type - facility type affects registration requirements and fees

Not obtaining DUNS number first - DUNS number is required for registration

## Frequently asked questions

### Who must register with FDA?

Medical device manufacturers, repackers, relabelers, specification developers, contract manufacturers, and certain other facilities must register. Foreign facilities that manufacture devices for US distribution must also register. Some exemptions apply for certain low-risk activities.

### What is the difference between registration and listing?

Registration is for facilities - it identifies the establishment. Listing is for devices - it identifies the specific devices being distributed. A facility must be registered before its devices can be listed. Registration is annual, listing is ongoing.

### When must I register with FDA?

Initial registration must be completed before beginning operations or distributing devices. Annual registration renewal is required between October 1 and December 31 each year. New facilities must register before their first commercial distribution.

### What is a DUNS number and do I need one?

DUNS (Data Universal Numbering System) number is a unique business identifier from Dun & Bradstreet. Yes, you need a DUNS number for FDA registration. It's free to obtain and typically takes 1-2 business days.

### How do I find the correct product code for my device?

FDA maintains a product classification database where you can search by device name or description to find the appropriate product code. The product code determines classification and regulatory requirements. Use the correct code to avoid compliance issues.

**Disclaimer:** This guide provides general information about FDA registration and listing. Facility-specific determinations require analysis of FDA regulations. Always verify current requirements with FDA resources or qualified regulatory professionals.

🇺🇸 US roadmap for your product

Every standard, document, and test that applies — free, no account required.

See your free roadmap[

Want an expert to take your product through 🇺🇸 US compliance for you?

One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts.

See compliance services](/services)

Related guides

*   [FDA Medical Device RegulationComplete guide to FDA medical device regulation.](/guides/fda-medical-device-regulation)
*   [US Medical Devices ClassificationComplete guide to US medical devices classification.](/guides/us-medical-devices-classification)
*   [US Quality System RegulationComplete guide to US Quality System Regulation.](/guides/us-quality-system-regulation)
*   [US Unique Device IdentificationComplete guide to US Unique Device Identification.](/guides/us-unique-device-identification)