Device Facilities Must Register with FDA

 

The 2009 Facility Annual Registration has expered, but you can still register your facility if you contact us now. We are here to help you with that process.

 

FDA Fees On October 1, 2008, FDA has introduced a process for collecting device facility (also known as “establishment”) user fees and registrations. Facilities now must pay their user fee before we can register the facility. Please follow this link to the FDA website for more information.

 

Affected Facilities You must pay the Device Facility User Fee to the FDA if you are a an manufacturer of devices that are commercially distributed in the U.S., a contract manufacturer or sterilizer whose device is shipped to the U.S. either by the contract manufacturer or by any other foreign establishment, a reprocessor of single-use devices commercially distributed in the U.S., a developer of specifications for a device that is manufactured by another party, or a kit Assembler. We have a link to the FDA database here.

 

Register & U.S. Agent Affected foreign device facilities must be registered with the FDA and a registration number will be provided. A foreign facility must also designate a U.S. agent, who can also register the foreign facility. Register-FDA is designated as an U.S. agent and is available to assist FDA in contacting the foreign facilities, act as a communications link between FDA and the facility and be able to register on behalf of the foreign facility. Only one U.S. agent per foreign facility is permitted.

 

Register Now We are here to assist you with the FDA registration process and we act as your U.S. Agent for the FDA.
   

Any payment option is accepted.
We accept credit card payments as well as bank transfers. All credit card payments are processed through our partner PayPal. If you prefer to pay by bank, we will send you an invoice first.

Solution Graphics
 


1. Select the service you want to purchase.
Below, you will find the option that allows you to register your device facility with the FDA and the assign us to act as your U.S. Agent.

2. Fill out the form.
Provide us with the information we need for the service. This form will take you less then 5 minutes to fill out.

3. Pay for the service.
You can pay online with your credit card, or you can request an invoice and pay by bank transfer. See our pricing.

 

 

 

 

 
  All inclusive price for one year:
 

Device Facility Registration & U.S. Agent

 

After you have paid your FDA fee (1851 USD), we register your device facilities, provide you with the official FDA registration number, a registration certificate to provide to your trading partners and we act as your U.S. Agent for all FDA device facility matters. Please follow the link to fill out our form.

 

 

540 USD

 

Including:

FDA Registration

U.S. Agent

Ongoing Maintenance

Unlimited Updates

(FDA fee not included)

 

 


Complete Solutions.
Our account with the FDA allows us to make submissions to FDA electronically via the Internet. FDA strongly encourages electronic submissions, which will be quicker and more convenient for both facilities and FDA.
Security is our Top Priority.
While using FDA Industry Systems (FIS), we comply with FDA standards on having current anti virus and antispyware software installed on our systems to help ensure the privacy of the information being entered.
Our Global Support.
We are specialized in supporting non-US based food facilities. Our processes are designed to process all registrations from companies located outside the USA.
Documentation.
You will receive a certificate of registration at the completion of the registration process with the FDA. This certificate can be used to notify all your trading partners. See a sample here.