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

When to Register and List

Establishments that are required to register and list must:

1. Submit registration and listing information within 30 days of an establishment beginning an activity.
2. Submit registration information annually, even if no changes have occurred, between October 1 and December 31.
3. Review all of their listing information on an annual basis ( between October 1 and December 31) at the same time they review their registration information and submit any updates at that time.

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 previous-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.

Additional information can be found in Device Advice When to Register and When to List.

Updated October 1, 2008