Registration and Listing
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.
Registration information must be submitted each year between October 1 and December 31, even if no changes have occurred. Listing information must be reviewed each year between October 1 and December 31, at the same time you review your registration information. Submit any updates at that time.
Submit registration and /or listing information within 30 days of an establishment beginning an activity or putting a device into commercial distribution. Foreign establishments must register before exporting products to the United States and domestic importers must register before importing products. Reminder that if your device requires premarket notification clearance or approval, you will have to wait until your premarket submission [510(k), PMA, etc.] is cleared or approved to register your establishment and list the device.
Update Registration & Listing Information
All owners or operators can access FURLS at any time throughout the year to update changes to their registration and listing information as those changes occur. Examples of changes to listings include:
- another device being introduced into commercial distribution,
- a change to a previously listed device, such as where it is being manufactured,
- a previously-listed device is removed from commercial distribution or commercial distribution is resumed.
Establishment registrations are based on FDA’s fiscal year which runs from October 1 to September 30. FDA will continue to consider an establishment’s registration active through the end of each calendar year.”
As FDA homepage stated above, Registration and Listing is one of compulsory requirements from FDA for foreign medical device manufacturer who wish to market their products in US.