FDA > CDRH > Registration & Listing > How to Register and List

How to Register and List

The MDUFMA II amendments require that all registration and listing information (new, updates, or annual review) be submitted electronically unless FDA grants you a waiver.

Registration and listing information is sent using the Internet through FDA’s Unified Registration and Listing System (FURLS). To use FURLS, each owner/operator must have an account ID and password. Firms who already registered in FY2008 should use their already assigned account ID and password. If you have never submitted establishment registration before, you will need to first create an account for the owner/operator. An owner/operator is defined as:

The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registered establishment.

The owner/operator can:

• Create and update all of the official correspondents’ FURLS accounts, including their own account(s)
• Assign official correspondents to registrations
• Create new registrations and listings
• Make changes, updates and cancellations to registrations and listings that they created
• View registration and listing information for the establishments that they created
• View all non-exempt listings belonging to the owner/operator that must be replaced

You will also be required to create sub account(s) for your official correspondent(s). An official correspondent is defined as:

The person designated by the owner or operator of an establishment responsible for the annual registration of the establishment and the device listing. The official correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm’s establishments.

The official correspondent is responsible for the registration and listing information for each establishment to which he/she is assigned. The official correspondent can:

• Create new registrations and listings
• Make changes, updates and cancellations to registrations and listings that have been assigned to them
• Add their establishment(s) to listings previously entered for the owner/operator
• View registration and listing information for the establishments which have been created by or assigned to them
• View the non-exempt listings that must be replaced for the establishments which have been assigned to them

To use FURLS:

1. Use the account ID and password to log on to our site at: https://www.access.fda.gov/oaa/
2. Review the registration information for your establishment and make any updates or enter your initial establishment registration information.
3. Review your listing information (if you are required to list your devices) and make updates or enter your initial listing information.

For each listing, you will need to identify whether your product requires premarket notification/approval or is exempt.

If your device requires premarket notification/approval you will:

• Enter the premarket submission number
• Enter the proprietary names
• Identify the activities that you perform on or to the devices

If your device is exempt from premarket notification/approval you will:

• Identify the product code
• Enter the proprietary names
• Identify the activities that you perform on or to the devices

4.  Submit the annual registration user fee

Note: your registration is not considered complete until you have submitted your information electronically, paid your registration user fee (if required to do so) and have received notification from FDA that all requirements have been met.

Waivers

The law requires that all registration and listing information be submitted electronically unless FDA grants a waiver. To apply for a waiver, please submit your request with a complete explanation of why you cannot submit your information through the Internet to:

Food and Drug Administration
Center for Devices and Radiological Health, HFZ-308
9200 Corporate Boulevard
Rockville, MD 20850-4015

Note: if you are granted a waiver, you will still be responsible for the establishment registration fee.

Updated June 10, 2008